hydromorphone ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
opioid receptor antagonists/agonists, morphinan derivates 1393 466-99-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • hydromorphone
  • dihydromorphinone
  • dihydromorphone
  • dimorphone
  • hydromorphon
  • hydromorphone hydrochloride
  • hydromorphone HCl
Hydromorphone is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of hydromorphone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with morphine. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression. The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.
  • Molecular weight: 285.34
  • Formula: C17H19NO3
  • CLOGP: 0.72
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 1
  • TPSA: 49.77
  • ALOGS: -1.81
  • ROTB: 0
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
20 mg O
4 mg P
4 mg R

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 10 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 6 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 1.20 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 42 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 4.30 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 28 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.86 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 2.30 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 0.971 Moderate 0.79
caco2-efflux Caco-2 efflux ratio (BA/AB) 1.403 Moderate 0.79
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 13.804 10^-6 cm/s Moderate 0.79
dh-clint Dog hepatocyte intrinsic clearance 40.272 uL/min/10^6 cells Moderate 0.79
dppb Dog plasma protein binding (% unbound) 70.910 % Moderate 0.79
fcs-ppb Fetal calf serum protein binding (% unbound) 78.480 % Moderate 0.79
herg hERG pIC50 4.771 pIC50 Moderate 0.79
hh-clint Human hepatocyte intrinsic clearance 4.571 uL/min/10^6 cells Moderate 0.79
hlm-clint Human liver microsomal intrinsic clearance 6.383 uL/min/mg protein Moderate 0.79
hppb Human plasma protein binding (% unbound) 70.100 % Moderate 0.79
kinase-safety-class ACVR2A,ACVR2B,AKT2,AKT3,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK2,CDK4,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GSK3B,IGF1R,ITK,JAK2,JAK3,KDR,MAP2K6,MAP3K14,MAP3K21,MAP3K7,MAPK10,MAPK7,MAPK9,MAPKAPK2,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CA,PIK3CB,PIM2,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK,ZAP70 53
kinase-selectivity-class EIF2AK3,GRK2,MAP2K6,MAP3K14,TEK 5
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 3.258 Moderate 0.79
mh-clint Mouse hepatocyte intrinsic clearance 176.198 Moderate 0.79
mppb Mouse plasma protein binding (% unbound) 69.860 Moderate 0.79
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 10.351 Moderate 0.79
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 83.400 % Moderate 0.79
rh-clint Rat hepatocyte intrinsic clearance 182.390 uL/min/10^6 cells Moderate 0.79
rh-fuinc Rat hepatocyte fraction unbound in incubation 88.610 % Moderate 0.79
rppb Rat plasma protein binding (% unbound) 60.600 % Moderate 0.79
solubility-dd Solubility at pH 7.4 in DMSO 941.890 uM Moderate 0.79

Approvals:

DateAgencyCompanyOrphan
Jan. 11, 1984 FDA PURDUE PHARM PRODS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug hypersensitivity 769.59 9.43 2282 170802 461327 89994036
Food allergy 508.62 9.43 408 172676 25070 90430293
Temperature regulation disorder 499.24 9.43 324 172760 14255 90441108
Immunodeficiency 372.44 9.43 436 172648 42798 90412565
Asthma 371.52 9.43 1161 171923 240999 90214364
Macular degeneration 342.29 9.43 392 172692 37578 90417785
Constipation 270.95 9.43 1157 171927 279238 90176125
Nasal oedema 219.72 9.43 144 172940 6440 90448923
Hyperhidrosis 215.74 9.43 661 172423 135644 90319719
Rash erythematous 207.37 9.43 413 172671 64691 90390672
Foetal death 180.12 9.43 210 172874 20513 90434850
Alopecia 176.67 9.43 431 172653 494640 89960723
Drug withdrawal syndrome 176.62 9.43 245 172839 28478 90426885
Rheumatoid arthritis 176.31 9.43 1241 171843 361373 90093990
Vaginal flatulence 170.62 9.43 162 172922 12476 90442887
Coeliac disease 170.60 9.43 306 172778 44304 90411059
Overdose 156.19 9.43 656 172428 157053 90298310
Proctitis 155.50 9.43 168 172916 15091 90440272
Vomiting 154.34 9.43 2233 170851 786060 89669303
Procedural pain 152.86 9.43 248 172836 33112 90422251
Female genital tract fistula 150.20 9.43 178 172906 17690 90437673
Radiculopathy 145.18 9.43 178 172906 18327 90437036
Therapeutic product effect incomplete 137.51 9.43 732 172352 193164 90262199
Pain 137.27 9.43 2665 170419 993676 89461687
Pneumonia viral 136.40 9.43 122 172962 8701 90446662
Soft tissue disorder 133.90 9.43 90 172994 4200 90451163
Back pain 132.80 9.43 1048 172036 316127 90139236
Sleep disorder due to general medical condition, insomnia type 131.48 9.43 41 173043 128653 90326710
Hyperaesthesia 123.65 9.43 126 172958 10576 90444787
Oedema 123.34 9.43 728 172356 199567 90255796
Vaginal discharge 121.13 9.43 167 172917 19297 90436066
Chronic sinusitis 120.18 9.43 185 172899 23617 90431746
Bursitis 119.88 9.43 534 172550 131120 90324243
Intentional product misuse 118.66 9.43 409 172675 89195 90366168
Somnolence 117.40 9.43 742 172342 208342 90247021
Swelling 113.21 9.43 415 172669 418643 90036720
Infusion site reaction 110.52 9.43 158 172926 18881 90436482
Systemic lupus erythematosus 110.31 9.43 340 172744 361556 90093807
Arthropathy 108.88 9.43 348 172736 365894 90089469
Fluid retention 108.82 9.43 393 172691 87698 90367665
Lower respiratory tract infection 107.03 9.43 197 172887 250462 90204901
Pneumonia aspiration 106.31 9.43 239 172845 40701 90414662
Upper respiratory tract infection 106.12 9.43 506 172578 127812 90327551
Pruritus 105.91 9.43 604 172480 540921 89914442
Prescribed overdose 103.65 9.43 415 172669 97210 90358153
Sinusitis 103.38 9.43 324 172760 342764 90112599
Respiratory rate decreased 99.70 9.43 73 173011 3910 90451453
Clostridium test positive 98.33 9.43 82 173002 5319 90450044
Drug dependence 98.15 9.43 190 172894 29137 90426226
Pemphigus 97.54 9.43 310 172774 326554 90128809
Paraesthesia oral 97.39 9.43 198 172886 31461 90423902
Abdominal discomfort 95.69 9.43 528 172556 476800 89978563
Blepharospasm 94.38 9.43 276 172808 55169 90400194
Taste disorder 93.17 9.43 294 172790 61252 90394111
Erythema 91.80 9.43 750 172334 228496 90226867
Glossodynia 87.95 9.43 317 172767 321462 90133901
Intentional overdose 87.11 9.43 35 173049 93799 90361564
Ankylosing spondylitis 86.75 9.43 116 172968 13017 90442346
Drug interaction 84.72 9.43 259 172825 276194 90179169
Unresponsive to stimuli 83.21 9.43 208 172876 37913 90417450
Nausea 82.09 9.43 2733 170351 1107583 89347780
Product dose omission issue 81.95 9.43 284 172800 291403 90163960
Drug intolerance 80.28 9.43 1250 171834 446341 90009022
Oral candidiasis 80.08 9.43 196 172888 35259 90420104
Hand deformity 78.33 9.43 296 172788 296066 90159297
Gastrooesophageal reflux disease 78.18 9.43 565 172519 165772 90289591
Pneumonia 77.05 9.43 1675 171409 636384 89818979
Respiratory tract infection 74.17 9.43 265 172819 58813 90396550
Ill-defined disorder 71.43 9.43 154 172930 184737 90270626
Hepatic cirrhosis 69.64 9.43 272 172812 62981 90392382
Hypermobility syndrome 69.42 9.43 34 173050 860 90454503
Myelosuppression 69.12 9.43 10 173074 53581 90401782
Extremity contracture 68.35 9.43 38 173046 1255 90454108
Drug ineffective for unapproved indication 68.10 9.43 280 172804 66364 90388999
Neutropenia 67.27 9.43 213 172871 224691 90230672
Exostosis 66.41 9.43 238 172846 52896 90402467
Bone erosion 64.16 9.43 235 172849 52786 90402577
Duodenal ulcer perforation 63.80 9.43 213 172871 221075 90234288
Respiratory depression 63.62 9.43 110 172974 15465 90439898
Gastrointestinal disorder 63.60 9.43 263 172821 256424 90198939
Device expulsion 62.22 9.43 4 173080 40882 90414481
Folliculitis 62.19 9.43 192 172892 204161 90251202
Injection site pain 61.20 9.43 152 172932 173547 90281816
Frequent bowel movements 61.19 9.43 243 172841 56692 90398671
Colitis 60.87 9.43 280 172804 69662 90385701
Inadequate analgesia 58.80 9.43 49 173035 3175 90452188
Malignant neoplasm progression 57.91 9.43 376 172708 106494 90348869
Sickle cell anaemia with crisis 55.32 9.43 69 173015 7228 90448135
Accidental death 54.60 9.43 39 173045 2009 90453354
Swollen tongue 54.19 9.43 202 172882 45754 90409609
Injection site erythema 54.09 9.43 65 173019 98437 90356926
Helicobacter infection 53.99 9.43 236 172848 226614 90228749
Abortion spontaneous 53.82 9.43 18 173066 54038 90401325
Back injury 53.37 9.43 203 172881 46419 90408944
Wheezing 53.05 9.43 691 172393 237389 90217974
Arthritis 52.87 9.43 520 172564 166795 90288568
Abdominal pain 52.27 9.43 1053 172031 394668 90060695
Decompression sickness 51.90 9.43 16 173068 106 90455257
Oral pain 51.19 9.43 158 172926 32525 90422838
Foetal exposure during pregnancy 51.04 9.43 10 173074 42965 90412398
C-reactive protein abnormal 51.00 9.43 104 172980 127325 90328038
Irritable bowel syndrome 50.48 9.43 214 172870 207234 90248129
Condition aggravated 49.72 9.43 819 172265 594726 89860637
Breast cancer metastatic 49.37 9.43 97 172987 15035 90440328
Device related thrombosis 49.34 9.43 37 173047 2056 90453307
Haematochezia 49.04 9.43 266 172818 70647 90384716
Narcotic bowel syndrome 48.97 9.43 16 173068 131 90455232
Joint dislocation 48.49 9.43 191 172893 44391 90410972
Drug diversion 47.90 9.43 28 173056 1019 90454344
Dysphonia 47.31 9.43 242 172842 62842 90392521
Pericarditis 47.13 9.43 312 172772 269839 90185524
Muscle injury 46.93 9.43 176 172908 176478 90278885
Hepatitis 46.44 9.43 40 173044 70699 90384664
Injection site reaction 46.20 9.43 65 173019 92015 90363348
Rash 45.59 9.43 1165 171919 794935 89660428
Suicide attempt 45.53 9.43 46 173038 75353 90380010
Injection site swelling 45.53 9.43 29 173055 59810 90395553
Implant site extravasation 45.41 9.43 22 173062 543 90454820
Medical device site pain 45.23 9.43 17 173067 218 90455145
Red blood cell sedimentation rate increased 44.99 9.43 291 172793 82304 90373059
Myocardial infarction 44.56 9.43 84 173000 105888 90349475
Contusion 44.39 9.43 289 172795 250927 90204436
Hepatic cytolysis 44.29 9.43 4 173080 30912 90424451
Blister 44.23 9.43 295 172789 254703 90200660
Cardiac failure congestive 42.59 9.43 77 173007 98617 90356746
Laryngitis 42.56 9.43 201 172883 50552 90404811
Rash pruritic 42.29 9.43 57 173027 82157 90373206
Discomfort 41.96 9.43 329 172755 274006 90181357
Weight increased 41.32 9.43 556 172528 417371 90037992
Malaise 41.18 9.43 1435 171649 584551 89870812
Pulmonary fibrosis 41.13 9.43 90 172994 107413 90347950
Colitis ulcerative 40.29 9.43 224 172860 60042 90395321
Impaired healing 40.08 9.43 272 172812 233927 90221436
Decreased immune responsiveness 40.02 9.43 65 173019 8683 90446680
Retinitis 39.62 9.43 162 172922 38296 90417067
Osteoporosis 39.23 9.43 317 172767 96214 90359149
Lactic acidosis 39.03 9.43 24 173060 50439 90404924
Maternal exposure during pregnancy 38.93 9.43 470 172614 359593 90095770
Wound 38.54 9.43 381 172703 302599 90152764
Drug reaction with eosinophilia and systemic symptoms 37.99 9.43 17 173067 42741 90412622
Knee arthroplasty 37.62 9.43 63 173021 83119 90372244
Anaphylactic reaction 37.53 9.43 291 172793 87233 90368130
Swollen joint count increased 37.10 9.43 100 172984 111106 90344257
Intentional self-injury 36.63 9.43 6 173078 29328 90426035
Coma 36.60 9.43 251 172833 72381 90382982
Infusion related reaction 36.43 9.43 1048 172036 415732 90039631
Eye irritation 36.20 9.43 10 173074 33968 90421395
Hip arthroplasty 36.08 9.43 56 173028 76152 90379211
Joint stiffness 36.01 9.43 264 172820 77778 90377585
Hepatic function abnormal 35.82 9.43 22 173062 46266 90409097
Faecal volume decreased 35.75 9.43 15 173069 261 90455102
Acute kidney injury 35.48 9.43 416 172668 319971 90135392
Orthostatic hypotension 35.07 9.43 18 173066 41809 90413554
Postmortem blood drug level increased 35.05 9.43 20 173064 695 90454668
Anti-cyclic citrullinated peptide antibody positive 35.01 9.43 286 172798 236147 90219216
Neoplasm progression 35.00 9.43 173 172911 44313 90411050
Drug eruption 34.88 9.43 12 173072 35395 90419968
Rectal haemorrhage 34.87 9.43 274 172810 82470 90372893
Liver disorder 34.75 9.43 117 172967 121152 90334211
Cholestasis 34.57 9.43 13 173071 36286 90419077
Epilepsy 34.52 9.43 272 172812 81934 90373429
Neck pain 34.44 9.43 351 172733 113612 90341751
Headache 34.43 9.43 1994 171090 860752 89594611
Cytomegalovirus infection 34.22 9.43 5 173079 26597 90428766
COVID-19 34.17 9.43 186 172898 168657 90286706
C-reactive protein increased 34.13 9.43 511 172573 180878 90274485
Pregnancy 34.00 9.43 41 173043 62006 90393357
Bradycardia 33.92 9.43 68 173016 83779 90371584
Dermatitis atopic 33.72 9.43 3 173081 23469 90431894
Granulocyte count increased 33.70 9.43 26 173058 1508 90453855
Antidepressant drug level above therapeutic 33.23 9.43 17 173067 473 90454890
Angioedema 32.57 9.43 224 172860 64652 90390711
Rheumatoid factor negative 32.42 9.43 18 173066 593 90454770
Injection site pruritus 32.33 9.43 33 173051 53801 90401562
Alveolitis 32.08 9.43 34 173050 2987 90452376
Food aversion 32.04 9.43 24 173060 1331 90454032
Hereditary angioedema 31.73 9.43 61 173023 9304 90446059
White blood cell count decreased 31.71 9.43 188 172896 166921 90288442
Drug tolerance decreased 31.46 9.43 11 173073 32119 90423244
Palpitations 31.46 9.43 144 172940 136584 90318779
Liver injury 31.26 9.43 194 172890 170373 90284990
Post cholecystectomy syndrome 31.19 9.43 20 173064 861 90454502
Acute chest syndrome 30.93 9.43 22 173062 1126 90454237
Interstitial lung disease 30.87 9.43 62 173022 76343 90379020
Cryopyrin associated periodic syndrome 30.87 9.43 17 173067 551 90454812
Psoriatic arthropathy 30.78 9.43 283 172801 228052 90227311
Weight decreased 30.67 9.43 946 172138 378964 90076399
Blood pressure fluctuation 30.61 9.43 188 172896 52225 90403138
Streptococcal sepsis 30.61 9.43 36 173048 3548 90451815
Overlap syndrome 30.60 9.43 57 173027 8491 90446872
Hypocalcaemia 30.27 9.43 22 173062 42346 90413017
No adverse event 30.27 9.43 52 173032 67930 90387433
Opiates positive 30.20 9.43 14 173070 312 90455051
Eye pruritus 30.08 9.43 9 173075 29018 90426345
Road traffic accident 30.05 9.43 105 172979 107521 90347842
Hepatotoxicity 29.99 9.43 26 173058 45816 90409547
Hepatocellular injury 29.97 9.43 9 173075 28949 90426414
Delirium 29.92 9.43 318 172766 104041 90351322
Overwork 29.68 9.43 9 173075 56 90455307
Foot deformity 29.38 9.43 205 172879 59446 90395917
Incorrect route of product administration 29.20 9.43 181 172903 50445 90404918
Small intestinal obstruction 29.03 9.43 98 172986 21136 90434227
Onychomycosis 28.59 9.43 18 173066 37358 90418005
Withdrawal syndrome 28.23 9.43 101 172983 22423 90432940
Nail bed inflammation 28.03 9.43 25 173059 1776 90453587
Red blood cell sedimentation rate abnormal 27.98 9.43 6 173078 24198 90431165
Agranulocytosis 27.98 9.43 16 173068 34986 90420377
Herpes zoster 27.89 9.43 290 172794 94354 90361009
Post-traumatic stress disorder 27.60 9.43 48 173036 6780 90448583
Therapy interrupted 27.57 9.43 33 173051 50075 90405288
Diarrhoea 27.19 9.43 1492 171592 937698 89517665
Rheumatoid factor positive 27.10 9.43 204 172880 171446 90283917
Electric shock 26.99 9.43 24 173060 1698 90453665
Rhesus antigen positive 26.91 9.43 10 173074 124 90455239
Toxicologic test abnormal 26.87 9.43 17 173067 715 90454648
Blood immunoglobulin A increased 26.57 9.43 21 173063 1262 90454101
Secondary amyloidosis 26.51 9.43 11 173073 186 90455177
Head banging 26.47 9.43 14 173070 418 90454945
Hypertensive encephalopathy 26.39 9.43 17 173067 738 90454625
Mental status changes 25.93 9.43 160 172924 44519 90410844
Deep vein thrombosis postoperative 25.69 9.43 61 173023 70748 90384615
Plasma cell myeloma 25.48 9.43 149 172935 40679 90414684
Nasal mucosal disorder 25.44 9.43 24 173060 1833 90453530
Lupus-like syndrome 25.32 9.43 170 172914 48676 90406687
Swelling face 25.27 9.43 252 172832 81100 90374263
Tenderness 25.20 9.43 110 172974 26758 90428605
Multiple sclerosis relapse 25.18 9.43 38 173046 52267 90403096
Tumour pain 25.11 9.43 24 173060 1863 90453500
Hypoaesthesia 24.98 9.43 781 172303 313429 90141934
Cardiac failure 24.78 9.43 116 172968 109380 90345983
Rheumatic fever 24.16 9.43 182 172902 152939 90302424
Eyelid injury 24.10 9.43 10 173074 169 90455194
Multiple organ dysfunction syndrome 23.90 9.43 60 173024 68276 90387087
Hyponatraemia 23.89 9.43 153 172931 133385 90321978
Premature baby 23.85 9.43 9 173075 25068 90430295
Sciatica 23.78 9.43 106 172978 101276 90354087
Platelet aggregation inhibition 23.58 9.43 10 173074 179 90455184
Iritis 23.50 9.43 32 173052 3654 90451709
Grip strength decreased 23.44 9.43 94 172990 92482 90362881
Blood pressure systolic increased 23.38 9.43 191 172893 58154 90397209
Status epilepticus 23.26 9.43 4 173080 18870 90436493
Labelled drug-drug interaction issue 23.25 9.43 25 173059 2233 90453130
Thrombocytopenia 23.21 9.43 542 172542 208183 90247180
Hemianopia 23.12 9.43 24 173060 2058 90453305
Febrile neutropenia 23.11 9.43 428 172656 157921 90297442
Screaming 23.07 9.43 32 173052 3718 90451645
Intestinal obstruction 22.84 9.43 135 172949 36996 90418367
Varicose vein 22.74 9.43 46 173038 7281 90448082
Ischaemic stroke 22.74 9.43 7 173077 22159 90433204
Bacillus infection 22.71 9.43 17 173067 942 90454421
Exposure during pregnancy 22.63 9.43 606 172478 237804 90217559
Biliary tract infection 22.34 9.43 16 173068 828 90454535
Basal ganglion degeneration 22.33 9.43 12 173072 370 90454993
Seasonal allergy 22.28 9.43 8 173076 22975 90432388
Urticaria 22.27 9.43 442 172642 312292 90143071
Endoscopic retrograde cholangiopancreatography 22.07 9.43 10 173074 211 90455152
Vitamin B12 increased 22.01 9.43 22 173062 1804 90453559
Renal impairment 21.95 9.43 115 172969 105306 90350057
Dry skin 21.94 9.43 90 172994 87983 90367380
Injection site urticaria 21.79 9.43 4 173080 18007 90437356
Basal cell carcinoma 21.77 9.43 19 173065 33370 90421993
Bronchomalacia 21.73 9.43 10 173074 219 90455144
Bursitis infective 21.62 9.43 20 173064 1490 90453873
Escherichia bacteraemia 21.48 9.43 39 173045 5696 90449667
Oxygen therapy 21.41 9.43 28 173056 3074 90452289
Therapy non-responder 21.32 9.43 163 172921 136541 90318822
Urticaria thermal 21.13 9.43 13 173071 520 90454843
Pseudomonal sepsis 21.10 9.43 33 173051 4269 90451094
Pyrexia 21.08 9.43 1498 171586 658987 89796376
Vascular device infection 20.82 9.43 60 173024 11892 90443471
Amputation stump pain 20.72 9.43 6 173078 31 90455332
Visual impairment 20.45 9.43 361 172723 132004 90323359
Migraine 20.13 9.43 491 172593 189901 90265462
Malignant polyp 20.08 9.43 9 173075 185 90455178
Sopor 20.08 9.43 11 173073 24633 90430730
Skin necrosis 20.00 9.43 4 173080 16937 90438426
Alanine aminotransferase increased 19.95 9.43 138 172946 118200 90337163
Glomerular filtration rate increased 19.80 9.43 22 173062 2038 90453325
Tissue infiltration 19.67 9.43 15 173069 855 90454508
Compartment syndrome 19.66 9.43 26 173058 2886 90452477
Rheumatoid nodule 19.58 9.43 7 173077 20159 90435204
Aspartate aminotransferase 19.43 9.43 14 173070 731 90454632
Scar 19.27 9.43 69 173015 15326 90440037
Adverse reaction 19.26 9.43 17 173067 29695 90425668
Poor venous access 19.13 9.43 81 173003 19446 90435917
Obstruction 19.13 9.43 30 173054 3891 90451472
C-reactive protein 19.09 9.43 19 173065 31348 90424015
Micrococcus infection 19.05 9.43 7 173077 84 90455279
Caesarean section 18.82 9.43 6 173078 18571 90436792
Ligament pain 18.73 9.43 9 173075 218 90455145
Pneumocystis jirovecii pneumonia 18.58 9.43 9 173075 21607 90433756
Septic shock 18.55 9.43 90 172994 84070 90371293
Immunoglobulins decreased 18.52 9.43 19 173065 1607 90453756
Confusional state 18.49 9.43 579 172505 385626 90069737
Stomatitis 18.44 9.43 392 172692 274306 90181057
Hyperkalaemia 18.39 9.43 63 173021 64901 90390462
Accidental exposure to product 18.32 9.43 33 173051 42333 90413030
Tubulointerstitial nephritis 18.32 9.43 13 173071 25330 90430033
Foreign body embolism 18.29 9.43 4 173080 4 90455359
Toe amputation 18.03 9.43 21 173063 2048 90453315
Gastrointestinal haemorrhage 17.93 9.43 100 172984 90148 90365215
Ocular hyperaemia 17.82 9.43 23 173061 33775 90421588
Hypothermia 17.72 9.43 4 173080 15571 90439792
Lactobacillus infection 17.69 9.43 7 173077 104 90455259
Anaesthesia 17.59 9.43 11 173073 453 90454910
Cholangitis infective 17.57 9.43 11 173073 454 90454909
Chest discomfort 17.57 9.43 174 172910 138191 90317172
Mucous stools 17.45 9.43 34 173050 5237 90450126
Breast cancer 17.44 9.43 49 173035 53712 90401651
Poisoning deliberate 17.29 9.43 5 173079 16481 90438882
Iodine allergy 17.28 9.43 14 173070 872 90454491
Administration site bruise 17.23 9.43 11 173073 470 90454893
Limb mass 17.22 9.43 27 173057 3501 90451862
Substance dependence 17.19 9.43 8 173076 180 90455183
Device difficult to use 17.16 9.43 6 173078 17519 90437844
Visual acuity reduced 16.93 9.43 12 173072 23398 90431965
Mucosal inflammation 16.91 9.43 55 173029 57570 90397793
Cholangitis sclerosing 16.83 9.43 21 173063 2200 90453163
Syncope 16.77 9.43 167 172917 132496 90322867
Adjustment disorder with depressed mood 16.77 9.43 54 173030 56699 90398664
Skin haemorrhage 16.77 9.43 10 173074 21370 90433993
Ocular procedural complication 16.74 9.43 10 173074 379 90454984
Dyspnoea exertional 16.70 9.43 76 173008 72212 90383151
Spinal pain 16.70 9.43 67 173017 15700 90439663
Product name confusion 16.57 9.43 7 173077 124 90455239
Neuralgia 16.55 9.43 110 172974 31390 90423973
Metastases to bone 16.51 9.43 94 172990 25411 90429952
Vitamin B12 deficiency 16.49 9.43 41 173043 7445 90447918
Anuria 16.48 9.43 4 173080 14814 90440549
Mental disorder 16.47 9.43 112 172972 32206 90423157
Lower limb fracture 16.46 9.43 95 172989 84918 90370445
Conjunctivitis 16.46 9.43 16 173068 26690 90428673
Monoplegia 16.40 9.43 27 173057 3647 90451716
Drug-induced liver injury 16.40 9.43 103 172981 90215 90365148
Extradural haematoma 16.39 9.43 20 173064 2048 90453315
Post procedural complication 16.39 9.43 76 173008 18966 90436397
Fear of disease 16.37 9.43 17 173067 1459 90453904
Pulmonary congestion 16.32 9.43 77 173007 19356 90436007
Nasopharyngitis 16.11 9.43 625 172459 406479 90048884
Melaena 16.06 9.43 26 173058 34771 90420592
Spinal disorder 16.05 9.43 54 173030 11625 90443738
Vision blurred 16.05 9.43 134 172950 110159 90345204
Adiposis dolorosa 15.98 9.43 9 173075 305 90455058
Drug abuse 15.87 9.43 233 172851 82114 90373249
Dry eye 15.84 9.43 57 173027 57874 90397489
Musculoskeletal stiffness 15.83 9.43 438 172646 296094 90159269
Psychotic disorder 15.71 9.43 22 173062 31208 90424155
Mitral valve incompetence 15.70 9.43 12 173072 22512 90432851
Toxic leukoencephalopathy 15.63 9.43 13 173071 840 90454523
Product use issue 15.58 9.43 775 172309 329144 90126219
Injury 15.57 9.43 274 172810 197075 90258288
Dysgeusia 15.54 9.43 50 173034 52510 90402853
Hepatic enzyme increased 15.53 9.43 840 172244 359896 90095467
Blood pressure diastolic decreased 15.52 9.43 96 172988 26730 90428633
Occipital neuralgia 15.37 9.43 12 173072 708 90454655
Transitional cell carcinoma metastatic 15.29 9.43 4 173080 13 90455350
Extrapyramidal disorder 15.26 9.43 6 173078 16297 90439066
Apnoea 15.20 9.43 46 173038 9368 90445995
Sinus congestion 15.15 9.43 18 173066 27406 90427957
Calcinosis 15.11 9.43 22 173062 2673 90452690
Neuroleptic malignant syndrome 15.07 9.43 5 173079 15091 90440272
Dental caries 15.06 9.43 52 173032 11345 90444018
Transient ischaemic attack 15.03 9.43 38 173046 43138 90412225
Accidental overdose 15.02 9.43 99 172985 28174 90427189
Aspartate aminotransferase increased 15.00 9.43 125 172959 102812 90352551
Sedation 14.85 9.43 149 172935 48022 90407341
Scratch 14.81 9.43 47 173037 9819 90445544
Intervertebral discitis 14.78 9.43 29 173055 4491 90450872
Product substitution issue 14.73 9.43 8 173076 18000 90437363
Dislocation of vertebra 14.70 9.43 56 173028 55912 90399451
Brain oedema 14.68 9.43 69 173015 17316 90438047
Presyncope 14.46 9.43 24 173060 31781 90423582
Rhinitis allergic 14.41 9.43 7 173077 16778 90438585
Medication overuse headache 14.38 9.43 16 173068 1485 90453878
Vitamin K deficiency 14.35 9.43 10 173074 495 90454868
Drug tolerance 14.33 9.43 70 173014 17846 90437517
Platelet count decreased 14.32 9.43 180 172904 136789 90318574
Obstructive airways disorder 14.27 9.43 17 173067 25852 90429511
Rash maculo-papular 14.26 9.43 36 173048 40897 90414466
Spinal cord compression 14.26 9.43 30 173054 4881 90450482
Product dose omission in error 14.19 9.43 11 173073 20492 90434871
Cerebral infarction 14.12 9.43 18 173066 26578 90428785
Product contamination microbial 14.02 9.43 8 173076 278 90455085
Injection site warmth 14.01 9.43 8 173076 17507 90437856
Chronic kidney disease 13.98 9.43 49 173035 50142 90405221
Rheumatoid factor increased 13.98 9.43 20 173064 2391 90452972
Candida infection 13.92 9.43 112 172972 33945 90421418
Radiation necrosis 13.90 9.43 11 173073 662 90454701
Dysphoria 13.87 9.43 34 173050 6120 90449243
Vaginal haemorrhage 13.85 9.43 24 173060 31247 90424116
Product storage error 13.83 9.43 11 173073 20230 90435133
Cerebrovascular accident 13.81 9.43 160 172924 123373 90331990
Blood pressure diastolic increased 13.80 9.43 55 173029 12851 90442512
Blood pressure systolic decreased 13.76 9.43 44 173040 9226 90446137
Silicon granuloma 13.71 9.43 3 173081 3 90455360
Virologic failure 13.71 9.43 19 173065 2205 90453158
Balance disorder 13.65 9.43 119 172965 96961 90358402
Abortion induced 13.63 9.43 3 173081 11885 90443478
Pulmonary arterial hypertension 13.62 9.43 18 173066 26169 90429194
Insomnia 13.62 9.43 510 172574 332964 90122399
Blood calcium decreased 13.51 9.43 23 173061 30159 90425204
Myelodysplastic syndrome 13.50 9.43 12 173072 20891 90434472
Breakthrough pain 13.48 9.43 15 173069 1392 90453971
Eosinophilia 13.47 9.43 21 173063 28512 90426851
Infection 13.45 9.43 832 172252 361262 90094101
Loss of personal independence in daily activities 13.44 9.43 181 172903 135924 90319439
Heart rate increased 13.42 9.43 296 172788 112606 90342757
Affect lability 13.41 9.43 9 173075 18054 90437309
Respiratory arrest 13.32 9.43 109 172975 33202 90422161
Wrong technique in product usage process 13.31 9.43 81 173003 71490 90383873
Fistula 13.31 9.43 52 173032 12037 90443326
Communication disorder 13.25 9.43 23 173061 3243 90452120
Injection site rash 13.21 9.43 16 173068 24157 90431206
Schizophrenia 13.14 9.43 6 173078 14908 90440455
Intervertebral disc protrusion 13.12 9.43 93 172991 27103 90428260
Eyelid oedema 13.05 9.43 3 173081 11531 90443832
Tooth abscess 13.03 9.43 64 173020 16349 90439014
Red cell distribution width increased 13.03 9.43 52 173032 12155 90443208
Groin pain 13.02 9.43 52 173032 12161 90443202
Blood triglycerides increased 12.99 9.43 5 173079 13756 90441607
Coronary artery disease 12.98 9.43 28 173056 33595 90421768
Administration site erythema 12.94 9.43 12 173072 897 90454466
Pancreatitis 12.85 9.43 196 172888 69630 90385733
Rash papular 12.77 9.43 12 173072 20343 90435020
Infusion site mobility decreased 12.72 9.43 5 173079 73 90455290
Intracranial pressure increased 12.65 9.43 35 173049 6776 90448587
Stevens-Johnson syndrome 12.60 9.43 23 173061 29353 90426010
Rectal fissure 12.56 9.43 11 173073 763 90454600
Skin laceration 12.54 9.43 89 172995 25946 90429417
Encephalitis brain stem 12.54 9.43 6 173078 144 90455219
Device failure 12.38 9.43 35 173049 6862 90448501
Oxygen saturation increased 12.36 9.43 8 173076 350 90455013
Seronegative arthritis 12.35 9.43 10 173074 18224 90437139
Postoperative ileus 12.31 9.43 10 173074 625 90454738
CFTR gene mutation 12.30 9.43 7 173077 242 90455121
Bone marrow failure 12.30 9.43 27 173057 32194 90423169
Uterine enlargement 12.28 9.43 14 173070 1334 90454029
Metastases to central nervous system 12.26 9.43 66 173018 17476 90437887
Implant site haematoma 12.24 9.43 5 173079 81 90455282
Oxygen saturation abnormal 12.23 9.43 26 173058 4262 90451101
Finger deformity 12.20 9.43 28 173056 32869 90422494
Pulmonary hypertension 12.19 9.43 41 173043 42482 90412881
Onychomadesis 12.18 9.43 138 172946 45860 90409503
Osteoarthritis 12.16 9.43 473 172611 195257 90260106
Insurance issue 12.10 9.43 3 173081 10955 90444408
Circulatory collapse 12.08 9.43 18 173066 24886 90430477
Metabolic acidosis 12.01 9.43 60 173024 55616 90399747
Therapeutic embolisation 11.99 9.43 7 173077 254 90455109
Lip dry 11.98 9.43 129 172955 100826 90354537
Nasal polyps 11.97 9.43 3 173081 10877 90444486
Eyelid haematoma 11.92 9.43 5 173079 87 90455276
Pain assessment 11.72 9.43 4 173080 38 90455325
Disease recurrence 11.71 9.43 35 173049 37618 90417745
Proteus test positive 11.68 9.43 8 173076 385 90454978
Umbilical discharge 11.66 9.43 5 173079 92 90455271
Inappropriate antidiuretic hormone secretion 11.66 9.43 12 173072 19493 90435870
Hypopnoea 11.65 9.43 26 173058 4405 90450958
Lymphopenia 11.63 9.43 16 173068 22865 90432498
Breast cancer female 11.62 9.43 7 173077 14879 90440484
Clostridium difficile infection 11.61 9.43 113 172971 36132 90419231
Product label confusion 11.59 9.43 16 173068 22834 90432529
Rubella 11.50 9.43 6 173078 174 90455189
Purpura 11.47 9.43 7 173077 14771 90440592
Localised infection 11.42 9.43 106 172978 33456 90421907
Blood pressure increased 11.42 9.43 473 172611 196744 90258619
Implant site pain 11.40 9.43 19 173065 2593 90452770
Substance abuse 11.28 9.43 29 173055 5377 90449986
Miliaria 11.27 9.43 14 173070 1460 90453903
Pulmonary toxicity 11.20 9.43 4 173080 11527 90443836
Hypersensitivity 11.18 9.43 1011 172073 453666 90001697
Pancreatic duct dilatation 11.17 9.43 8 173076 414 90454949
Type 2 diabetes mellitus 11.15 9.43 299 172785 202945 90252418
Haematotoxicity 11.11 9.43 5 173079 12530 90442833
Epstein-Barr virus infection 11.10 9.43 3 173081 10341 90445022
Pseudostroke 11.10 9.43 5 173079 104 90455259
Carbohydrate antigen 19-9 increased 11.09 9.43 7 173077 293 90455070
Klebsiella test positive 11.06 9.43 14 173070 1489 90453874
Vulvovaginal inflammation 11.03 9.43 12 173072 1086 90454277
Complement factor C4 decreased 11.03 9.43 7 173077 296 90455067
Infusion site mass 11.03 9.43 17 173067 2172 90453191
Osteonecrosis of jaw 11.01 9.43 38 173046 39065 90416298
Photophobia 11.01 9.43 74 173010 21195 90434168
Medical device site infection 10.98 9.43 8 173076 425 90454938
Perineal pain 10.92 9.43 9 173075 574 90454789
Eye operation 10.89 9.43 19 173065 2690 90452673
Foreign body reaction 10.85 9.43 5 173079 110 90455253
Defaecation disorder 10.84 9.43 11 173073 918 90454445
Rib fracture 10.84 9.43 87 172997 26348 90429015
Breast pain 10.82 9.43 44 173040 10374 90444989
Blood glucose increased 10.78 9.43 123 172961 95123 90360240
Complement factor C3 decreased 10.76 9.43 7 173077 309 90455054
Maternal exposure before pregnancy 10.71 9.43 4 173080 11209 90444154
Akathisia 10.62 9.43 4 173080 11155 90444208
Rhabdomyolysis 10.62 9.43 56 173028 51200 90404163
Miosis 10.61 9.43 41 173043 9443 90445920
Dizziness 10.60 9.43 975 172109 588309 89867054
Heart rate irregular 10.57 9.43 81 173003 24187 90431176
Stomatococcal infection 10.56 9.43 5 173079 117 90455246
Drug ineffective 10.51 9.43 2881 170203 1381417 89073946
Amphetamines positive 10.48 9.43 6 173078 210 90455153
Respiratory tract inflammation 10.44 9.43 9 173075 611 90454752
Lower respiratory tract infection viral 10.43 9.43 11 173073 961 90454402
Blood immunoglobulin M decreased 10.41 9.43 13 173071 1364 90453999
Soft tissue swelling 10.40 9.43 13 173071 1365 90453998
Food intolerance 10.37 9.43 23 173061 3879 90451484
Sepsis 10.35 9.43 431 172653 179383 90275980
Intestinal metastasis 10.30 9.43 6 173078 217 90455146
Bone pain 10.28 9.43 171 172913 61812 90393551
Rubber sensitivity 10.26 9.43 19 173065 2818 90452545
Apnoeic attack 10.24 9.43 7 173077 336 90455027
Liver iron concentration abnormal 10.20 9.43 4 173080 58 90455305
Fall 10.19 9.43 787 172297 481023 89974340
Polyarthritis 10.19 9.43 12 173072 18338 90437025
Dyschezia 10.13 9.43 19 173065 2846 90452517
Eye swelling 10.12 9.43 26 173058 29360 90426003
Ileus 10.07 9.43 60 173024 16486 90438877
Tachyphylaxis 10.06 9.43 7 173077 346 90455017
Feeding intolerance 10.04 9.43 11 173073 1003 90454360
Acne 9.99 9.43 25 173059 28482 90426881
Genital prolapse 9.96 9.43 4 173080 62 90455301
Brain injury 9.96 9.43 35 173049 7703 90447660
Allodynia 9.96 9.43 11 173073 1013 90454350
Dyskinesia 9.95 9.43 36 173048 36498 90418865
Autoimmune disorder 9.95 9.43 96 172988 76648 90378715
Acute generalised exanthematous pustulosis 9.94 9.43 7 173077 13696 90441667
Renal cyst 9.93 9.43 50 173034 12900 90442463
Exposure via skin contact 9.92 9.43 4 173080 10701 90444662
Monocyte count increased 9.91 9.43 39 173045 9058 90446305
Lip swelling 9.90 9.43 39 173045 38571 90416792
Left ventricular dilatation 9.89 9.43 9 173075 656 90454707
Metastatic renal cell carcinoma 9.89 9.43 10 173074 831 90454532
Pancreatitis acute 9.88 9.43 30 173054 32085 90423278
Eye pain 9.87 9.43 47 173037 44121 90411242
Psychiatric symptom 9.86 9.43 33 173051 7085 90448278
Ataxia 9.80 9.43 12 173072 18030 90437333
Bowel movement irregularity 9.75 9.43 31 173053 6483 90448880
Chronic gastrointestinal bleeding 9.71 9.43 5 173079 141 90455222
Gingival abscess 9.70 9.43 11 173073 1042 90454321
Paraneoplastic dermatomyositis 9.62 9.43 5 173079 144 90455219
Aptyalism 9.60 9.43 9 173075 682 90454681
Gastrointestinal pathogen panel 9.59 9.43 3 173081 21 90455342
Wound infection bacterial 9.59 9.43 9 173075 683 90454680
Toxic epidermal necrolysis 9.58 9.43 31 173053 32497 90422866
Body temperature decreased 9.56 9.43 78 173006 23738 90431625
Diaphragmatic paralysis 9.54 9.43 9 173075 687 90454676
Personality disorder 9.51 9.43 6 173078 12438 90442925
Central nervous system infection 9.51 9.43 10 173074 871 90454492
Nephrolithiasis 9.50 9.43 139 172945 48946 90406417
Bacterial test negative 9.47 9.43 3 173081 22 90455341
Haematoma infection 9.47 9.43 9 173075 694 90454669
Disturbance in attention 9.47 9.43 52 173032 47057 90408306

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Sedation 309.12 11.28 326 76735 30149 42514125
Appendicolith 289.01 11.28 220 76841 13236 42531038
Drug dependence 237.76 11.28 278 76783 28816 42515458
Inspiratory capacity decreased 236.82 11.28 113 76948 2854 42541420
Appendicitis 229.74 11.28 232 76829 20381 42523893
Hyperaesthesia 219.85 11.28 136 76925 5816 42538458
Nausea 209.60 11.28 1328 75733 395471 42148803
Stress 178.34 11.28 301 76760 43911 42500363
Constipation 170.12 11.28 661 76400 161630 42382644
Respiratory depression 150.32 11.28 178 76883 18690 42525584
Blood phosphorus increased 146.97 11.28 145 76916 12380 42531894
Nightmare 145.71 11.28 202 76859 24810 42519464
Drug withdrawal syndrome 137.64 11.28 182 76879 21367 42522907
Cardiogenic shock 131.10 11.28 233 76828 35407 42508867
Hyperhidrosis 125.12 11.28 404 76657 90108 42454166
Neuralgia 124.47 11.28 190 76871 25457 42518817
Abdominal distension 123.51 11.28 346 76715 71389 42472885
Drug therapy 116.89 11.28 95 76966 6285 42537989
Nephrolithiasis 113.27 11.28 223 76838 36607 42507667
Abdominal pain 111.10 11.28 655 76406 189816 42354458
Pain 110.43 11.28 789 76272 244059 42300215
General physical health deterioration 108.98 11.28 551 76510 150695 42393579
Ascites 107.16 11.28 283 76778 56395 42487879
Ventricular fibrillation 105.76 11.28 193 76868 29930 42514344
Myasthenia gravis 104.14 11.28 137 76924 16000 42528274
Vomiting 101.16 11.28 880 76181 288843 42255431
Sleep disorder therapy 100.43 11.28 90 76971 6804 42537470
Hypophosphataemia 99.99 11.28 154 76907 20791 42523483
Hyperphosphataemia 95.93 11.28 118 76943 12886 42531388
Incorrect route of product administration 89.50 11.28 159 76902 24146 42520128
Iron deficiency 85.87 11.28 103 76958 10958 42533316
Somnolence 84.63 11.28 489 76572 140616 42403658
Pelvic pain 82.92 11.28 59 77002 3195 42541079
Febrile neutropenia 82.79 11.28 597 76464 185106 42359168
Drug hypersensitivity 81.55 11.28 376 76685 99013 42445261
Victim of child abuse 76.19 11.28 39 77022 1150 42543124
Epidural lipomatosis 73.85 11.28 44 77017 1756 42542518
Hyponatraemia 73.26 11.28 370 76691 101092 42443182
Blood uric acid increased 72.37 11.28 113 76948 15434 42528840
Child abuse 71.27 11.28 34 77027 858 42543416
Bacterial infection 69.59 11.28 155 76906 27724 42516550
Toxicologic test abnormal 65.62 11.28 27 77034 473 42543801
Dry mouth 64.36 11.28 188 76873 39691 42504583
Terminal insomnia 64.32 11.28 32 77029 887 42543387
Antacid therapy 63.66 11.28 59 77002 4658 42539616
Sleep disorder 63.10 11.28 211 76850 47884 42496390
Inadequate analgesia 61.52 11.28 49 77012 3148 42541126
Interstitial lung disease 60.81 11.28 33 77028 78429 42465845
Juvenile idiopathic arthritis 60.76 11.28 45 77016 2594 42541680
Chest injury 60.69 11.28 39 77022 1783 42542491
Anticoagulant therapy 59.81 11.28 56 77005 4479 42539795
Drug interaction 56.74 11.28 269 76792 266730 42277544
Acute kidney injury 55.85 11.28 412 76649 366925 42177349
Blood cholesterol increased 55.14 11.28 138 76923 26603 42517671
Intentional product misuse 54.35 11.28 239 76822 61661 42482613
Cardiac failure 54.30 11.28 68 76993 106788 42437486
Decerebrate posture 53.51 11.28 17 77044 134 42544140
Back pain 53.20 11.28 438 76623 141338 42402936
Product prescribing error 52.01 11.28 133 76928 25979 42518295
Postmortem blood drug level abnormal 51.29 11.28 21 77040 363 42543911
Clostridium test positive 50.70 11.28 56 77005 5449 42538825
Neutropenia 49.68 11.28 189 76872 199242 42345032
Activated partial thromboplastin time prolonged 48.52 11.28 96 76965 15807 42528467
Swelling 48.25 11.28 212 76849 54673 42489601
Drug tolerance 46.05 11.28 42 77019 3248 42541026
Myocardial infarction 46.04 11.28 97 76964 123912 42420362
Unresponsive to stimuli 45.92 11.28 143 76918 31260 42513014
Blood calcium increased 45.85 11.28 66 76995 8388 42535886
Parkinsonism hyperpyrexia syndrome 45.81 11.28 19 77042 340 42543934
Product used for unknown indication 45.77 11.28 28 77033 1173 42543101
Mechanical ventilation complication 44.84 11.28 23 77038 681 42543593
Medical device site pain 44.26 11.28 13 77048 76 42544198
Respiratory rate decreased 43.99 11.28 39 77022 2906 42541368
Ulcer 43.97 11.28 94 76967 16347 42527927
Myoclonus 42.72 11.28 95 76966 16970 42527304
Blood test abnormal 41.92 11.28 80 76981 12826 42531448
Rash 41.85 11.28 311 76750 276643 42267631
Renal failure 39.93 11.28 130 76931 143596 42400678
Product dose omission issue 39.27 11.28 145 76916 154220 42390054
Apnoeic attack 39.16 11.28 19 77042 498 42543776
Hepatic function abnormal 38.08 11.28 23 77038 51544 42492730
Systemic infection 36.41 11.28 46 77015 5159 42539115
Cardiac failure congestive 36.11 11.28 62 76999 85540 42458734
Delirium 35.42 11.28 188 76873 52331 42491943
Painful respiration 35.29 11.28 25 77036 1344 42542930
Rhabdomyolysis 35.26 11.28 54 77007 77965 42466309
Drug reaction with eosinophilia and systemic symptoms 35.15 11.28 16 77045 42059 42502215
Drug abuse 34.73 11.28 315 76746 104456 42439818
Arachnoiditis 34.50 11.28 16 77045 378 42543896
Withdrawal syndrome 34.48 11.28 80 76981 14695 42529579
Serotonin syndrome 34.43 11.28 114 76947 25731 42518543
Total lung capacity decreased 34.07 11.28 37 77024 3533 42540741
Troponin increased 33.80 11.28 93 76968 18969 42525305
Injection site warmth 33.23 11.28 32 77029 2651 42541623
Mental status changes 32.79 11.28 157 76904 41958 42502316
Syncope 32.66 11.28 83 76978 99323 42444951
Bronchopulmonary aspergillosis allergic 31.16 11.28 40 77021 4558 42539716
Blood creatine phosphokinase increased 31.13 11.28 25 77036 48313 42495961
Prostate cancer metastatic 30.59 11.28 48 77013 6581 42537693
End stage renal disease 30.58 11.28 82 76979 16476 42527798
Bacteroides infection 30.44 11.28 30 77031 2557 42541717
Renal impairment 30.40 11.28 100 76961 110128 42434146
Postoperative ileus 30.06 11.28 18 77043 725 42543549
Eosinophilia 29.93 11.28 11 77050 32888 42511386
Multiple organ dysfunction syndrome 29.78 11.28 287 76774 96748 42447526
Cerebrovascular accident 29.75 11.28 84 76977 97076 42447198
Congenital hiatus hernia 28.90 11.28 45 77016 6129 42538145
COVID-19 28.76 11.28 110 76951 115838 42428436
Plasma cell myeloma 28.53 11.28 165 76896 47413 42496861
Xyphoid retraction 28.48 11.28 11 77050 162 42544112
Tumour fistulisation 28.28 11.28 10 77051 113 42544161
Sepsis 27.97 11.28 511 76550 198823 42345451
Lung opacity 27.96 11.28 43 77018 5794 42538480
Device power source issue 27.80 11.28 16 77045 598 42543676
Thrombosis 27.48 11.28 215 76846 68296 42475978
Adverse reaction 27.47 11.28 35 77026 3958 42540316
Lymphoedema 27.37 11.28 39 77022 4909 42539365
Suicide attempt 27.08 11.28 26 77035 46074 42498200
Anaemia of malignant disease 26.93 11.28 15 77046 526 42543748
Gastrointestinal haemorrhage 26.71 11.28 89 76972 97637 42446637
Drug tolerance increased 26.59 11.28 14 77047 438 42543836
Injection site mass 26.44 11.28 52 77009 8523 42535751
Musculoskeletal stiffness 26.41 11.28 187 76874 57578 42486696
Tubulointerstitial nephritis 26.35 11.28 12 77049 31536 42512738
Cytomegalovirus infection 25.89 11.28 13 77048 32293 42511981
Kidney infection 25.83 11.28 45 77016 6725 42537549
Drug intolerance 25.73 11.28 240 76821 80184 42464090
Eczema 25.45 11.28 15 77046 34071 42510203
Epilepsy 25.11 11.28 8 77053 26163 42518111
Atrial fibrillation 24.93 11.28 149 76912 139444 42404830
Congenital megacolon 24.76 11.28 8 77053 67 42544207
Liver function test increased 24.69 11.28 86 76975 19912 42524362
Walking aid user 24.62 11.28 27 77034 2606 42541668
Opiates positive 24.09 11.28 14 77047 533 42543741
Palpitations 24.08 11.28 34 77027 50763 42493511
Toxicity to various agents 23.81 11.28 562 76499 228574 42315700
Cerebral haemorrhage 22.86 11.28 22 77039 38944 42505330
Implant site pain 22.39 11.28 9 77052 148 42544126
Aspiration 22.15 11.28 77 76984 17809 42526465
Hypoglycaemia 22.05 11.28 47 77014 59807 42484467
Respiratory syncytial virus bronchitis 21.97 11.28 8 77053 99 42544175
Pleuritic pain 21.92 11.28 43 77018 7034 42537240
Thrombocytopenia 21.91 11.28 229 76832 190050 42354224
Neck pain 21.31 11.28 109 76952 29905 42514369
Neurotoxicity 21.26 11.28 92 76969 23559 42520715
Administration related reaction 21.16 11.28 9 77052 172 42544102
Rash maculo-papular 21.06 11.28 22 77039 37481 42506793
Hyperkalaemia 20.82 11.28 75 76986 80383 42463891
No adverse event 20.69 11.28 24 77037 38997 42505277
Angioedema 20.56 11.28 28 77033 42449 42501825
Substance abuse 20.54 11.28 48 77013 8857 42535417
Chylothorax 20.49 11.28 17 77044 1157 42543117
Drug resistance 20.49 11.28 19 77042 34229 42510045
Overdose 20.46 11.28 285 76776 104979 42439295
Pneumocystis jirovecii pneumonia 20.38 11.28 10 77051 25171 42519103
Cerebral infarction 20.22 11.28 16 77045 31153 42513121
Ventricular tachycardia 20.18 11.28 15 77046 30145 42514129
Injection related reaction 20.06 11.28 13 77048 603 42543671
Aortic stenosis 20.02 11.28 47 77014 8698 42535576
Confusional state 19.89 11.28 419 76642 167178 42377096
Burning sensation 19.87 11.28 83 76978 20930 42523344
Lactic acidosis 19.80 11.28 32 77029 45229 42499045
Hepatocellular injury 19.78 11.28 9 77052 23669 42520605
Sputum discoloured 19.54 11.28 51 77010 10081 42534193
Tumour perforation 19.52 11.28 12 77049 507 42543767
Chronic obstructive pulmonary disease 19.51 11.28 187 76874 62927 42481347
Seizure like phenomena 19.39 11.28 16 77045 1081 42543193
Intentional overdose 19.29 11.28 40 77021 51416 42492858
Myelosuppression 19.26 11.28 27 77034 40434 42503840
Congenital megaureter 19.14 11.28 8 77053 146 42544128
Arrhythmia 19.09 11.28 27 77034 40290 42503984
Myalgia 19.09 11.28 99 76962 95981 42448293
Blood pressure systolic increased 18.77 11.28 100 76961 27868 42516406
Status epilepticus 18.45 11.28 3 77058 15575 42528699
Melaena 18.30 11.28 26 77035 38720 42505554
Oesophageal infection 18.21 11.28 10 77051 341 42543933
Diabetes mellitus 18.07 11.28 177 76884 59910 42484364
Respiratory arrest 17.98 11.28 100 76961 28324 42515950
Forced expiratory flow decreased 17.86 11.28 8 77053 174 42544100
Treatment failure 17.82 11.28 56 77005 62568 42481706
Extrapyramidal disorder 17.66 11.28 4 77057 16408 42527866
Foreign body embolism 17.62 11.28 4 77057 6 42544268
Abdominal pain lower 17.61 11.28 55 77006 12037 42532237
Bradycardia 17.59 11.28 87 76974 85397 42458877
Sinusitis 17.53 11.28 37 77024 47255 42497019
Microembolism 17.51 11.28 5 77056 26 42544248
Acute myocardial infarction 17.28 11.28 51 77010 58114 42486160
Pulmonary embolism 17.23 11.28 308 76753 119304 42424970
Device kink 17.19 11.28 11 77050 499 42543775
Hot flush 17.16 11.28 83 76978 22268 42522006
Malignant neoplasm progression 17.01 11.28 283 76778 108117 42436157
Basal cell carcinoma 16.97 11.28 10 77051 22723 42521551
Death 16.88 11.28 1026 76035 470159 42074115
Substance dependence 16.86 11.28 12 77049 650 42543624
Bone marrow failure 16.86 11.28 21 77040 33072 42511202
Skin exfoliation 16.70 11.28 31 77030 41522 42502752
Oral herpes 16.68 11.28 40 77021 7504 42536770
Poor venous access 16.63 11.28 39 77022 7213 42537061
Gout 16.62 11.28 97 76964 27958 42516316
Rectal haemorrhage 16.61 11.28 41 77020 49565 42494709
Musculoskeletal pain 16.46 11.28 110 76951 33230 42511044
Blood pressure diastolic increased 16.42 11.28 36 77025 6369 42537905
Blood pressure diastolic abnormal 16.34 11.28 35 77026 6093 42538181
Type IIa hyperlipidaemia 16.33 11.28 9 77052 309 42543965
Ischaemic stroke 16.29 11.28 10 77051 22223 42522051
Mucosal atrophy 16.14 11.28 6 77055 79 42544195
Pancreatic carcinoma metastatic 16.13 11.28 24 77037 3142 42541132
Oesophageal mucosa erythema 16.01 11.28 5 77056 37 42544237
Joint debridement 15.95 11.28 3 77058 0 42544274
Hyperlipidaemia 15.88 11.28 79 76982 21437 42522837
Angiopathy 15.85 11.28 32 77029 5345 42538929
Anaesthetic complication neurological 15.72 11.28 12 77049 724 42543550
Antasthmatic drug level 15.67 11.28 5 77056 40 42544234
Prostate cancer 15.66 11.28 36 77025 44607 42499667
Blood pressure increased 15.59 11.28 265 76796 101663 42442611
Sickle cell anaemia with crisis 15.50 11.28 30 77031 4860 42539414
Urinary tract disorder 15.43 11.28 21 77040 2533 42541741
Lymphopenia 15.39 11.28 10 77051 21553 42522721
Analgesic drug level 15.36 11.28 5 77056 43 42544231
Shock symptom 15.23 11.28 7 77054 162 42544112
Neutrophil count decreased 15.18 11.28 61 77000 63354 42480920
Blood glucose increased 15.17 11.28 75 76986 73624 42470650
Coma 15.16 11.28 48 77013 53506 42490768
Spinal shock 15.16 11.28 5 77056 45 42544229
Delirium tremens 15.05 11.28 11 77050 621 42543653
Alanine aminotransferase increased 14.92 11.28 96 76965 88310 42455964
Sleep deficit 14.92 11.28 13 77048 946 42543328
Aspergillus infection 14.91 11.28 5 77056 15832 42528442
Protein deficiency 14.81 11.28 8 77053 264 42544010
Arteriosclerosis 14.78 11.28 7 77054 17982 42526292
Therapeutic product effect incomplete 14.71 11.28 72 76989 70867 42473407
Haemorrhoids thrombosed 14.70 11.28 8 77053 268 42544006
Platelet count decreased 14.66 11.28 170 76891 138411 42405863
Cholestasis 14.62 11.28 23 77038 32856 42511418
Intensive care 14.33 11.28 14 77047 1180 42543094
Immune-mediated hepatitis 14.29 11.28 25 77036 3749 42540525
Pulmonary hypertension 14.19 11.28 13 77048 23556 42520718
Thymic cancer metastatic 13.95 11.28 5 77056 59 42544215
Burkholderia test positive 13.91 11.28 13 77048 1037 42543237
Metastasis 13.87 11.28 28 77033 4677 42539597
Device computer issue 13.82 11.28 4 77057 22 42544252
Fasciotomy 13.80 11.28 5 77056 61 42544213
Axillary pain 13.78 11.28 9 77052 423 42543851
Facial wasting 13.72 11.28 6 77055 123 42544151
Drug withdrawal syndrome neonatal 13.69 11.28 27 77034 4434 42539840
Alpha haemolytic streptococcal infection 13.61 11.28 17 77044 1885 42542389
Haematuria 13.58 11.28 56 77005 57743 42486531
Erectile dysfunction 13.56 11.28 15 77046 24898 42519376
Tenderness 13.49 11.28 41 77020 8842 42535432
Sinus bradycardia 13.45 11.28 5 77056 14848 42529426
Postoperative delirium 13.30 11.28 10 77051 590 42543684
Breath sounds abnormal 13.23 11.28 50 77011 12043 42532231
Diarrhoea 13.22 11.28 690 76371 460159 42084115
Ankle fracture 13.22 11.28 28 77033 4838 42539436
Allergy to metals 13.21 11.28 6 77055 135 42544139
International normalised ratio increased 13.06 11.28 44 77017 48124 42496150
Streptococcal bacteraemia 12.97 11.28 20 77041 2702 42541572
Endotracheal intubation 12.96 11.28 24 77037 3761 42540513
Hallucination 12.96 11.28 160 76901 57347 42486927
Osteoarthritis 12.95 11.28 82 76979 24323 42519951
Failure to thrive 12.94 11.28 42 77019 9380 42534894
Wheezing 12.92 11.28 53 77008 54728 42489546
Hip surgery 12.91 11.28 14 77047 1334 42542940
Muscle spasticity 12.81 11.28 34 77027 6788 42537486
Dysphonia 12.55 11.28 20 77041 28430 42515844
Therapy interrupted 12.55 11.28 13 77048 22237 42522037
Drug-induced liver injury 12.53 11.28 32 77029 38241 42506033
Dyspnoea paroxysmal nocturnal 12.43 11.28 15 77046 1605 42542669
Glycosylated haemoglobin increased 12.31 11.28 4 77057 12920 42531354
Device related bacteraemia 12.20 11.28 10 77051 669 42543605
Body temperature decreased 12.15 11.28 55 77006 14358 42529916
Post-thoracotomy pain syndrome 12.12 11.28 4 77057 36 42544238
Psoriasis 12.11 11.28 46 77015 48558 42495716
Postmortem blood drug level 12.10 11.28 6 77055 165 42544109
Therapy partial responder 12.10 11.28 11 77050 20010 42524264
Lip swelling 12.08 11.28 10 77051 19043 42525231
Infantile back arching 12.08 11.28 5 77056 89 42544185
Infusion site mass 12.06 11.28 8 77053 386 42543888
Disease recurrence 12.05 11.28 22 77039 29656 42514618
Progressive multifocal leukoencephalopathy 12.04 11.28 3 77058 11533 42532741
Bladder cancer 12.04 11.28 8 77053 17039 42527235
Brief psychotic disorder with marked stressors 12.03 11.28 7 77054 267 42544007
Rash erythematous 11.98 11.28 25 77036 32066 42512208
Drug level increased 11.96 11.28 18 77043 26182 42518092
Neuropathy peripheral 11.95 11.28 122 76939 101731 42442543
Injection site swelling 11.94 11.28 8 77053 16965 42527309
Pathogen resistance 11.91 11.28 3 77058 11447 42532827
Device malfunction 11.89 11.28 49 77012 12278 42531996
Haemothorax 11.83 11.28 28 77033 5208 42539066
Harlequin syndrome 11.81 11.28 3 77058 9 42544265
Analgesic therapy 11.73 11.28 32 77029 6492 42537782
Oedema mucosal 11.66 11.28 12 77049 1077 42543197
Palmar-plantar erythrodysaesthesia syndrome 11.64 11.28 12 77049 20570 42523704
Allodynia 11.61 11.28 12 77049 1082 42543192
Joint swelling 11.57 11.28 180 76881 67842 42476432
Camptocormia 11.57 11.28 6 77055 182 42544092
Bone infarction 11.51 11.28 7 77054 290 42543984
Device infusion issue 11.49 11.28 12 77049 1096 42543178
Gastrointestinal scarring 11.48 11.28 6 77055 185 42544089
Visual acuity reduced 11.39 11.28 9 77052 17541 42526733

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug hypersensitivity 694.49 9.96 2216 215367 451874 109919842
Temperature regulation disorder 441.03 9.96 289 217294 12537 110359179
Constipation 417.85 9.96 1598 215985 356188 110015528
Food allergy 345.51 9.96 298 217285 19650 110352066
Hyperaesthesia 307.11 9.96 245 217338 14482 110357234
Asthma 283.02 9.96 1107 216476 249184 110122532
Appendicolith 273.72 9.96 226 217357 14029 110357687
Drug withdrawal syndrome 264.80 9.96 350 217233 37704 110334012
Hyperhidrosis 251.64 9.96 876 216707 186422 110185294
Pain 240.89 9.96 2902 214681 952053 109419663
Immunodeficiency 233.74 9.96 333 217250 38505 110333211
Vomiting 228.54 9.96 2765 214818 907910 109463806
Nausea 223.81 9.96 3539 214044 1232151 109139565
Nasal oedema 215.59 9.96 146 217437 6693 110365023
Sedation 206.89 9.96 437 217146 69246 110302470
Inspiratory capacity decreased 196.68 9.96 98 217485 2497 110369219
Back pain 187.43 9.96 1311 216272 369685 110002031
Somnolence 185.75 9.96 1109 216474 296340 110075376
Respiratory depression 183.25 9.96 268 217315 31733 110339983
Drug dependence 175.13 9.96 336 217247 49684 110322032
Appendicitis 168.26 9.96 242 217341 28222 110343494
Rheumatoid arthritis 168.22 9.96 1087 216496 298526 110073190
Coeliac disease 164.79 9.96 301 217282 42886 110328830
Drug interaction 162.25 9.96 477 217106 499706 109872010
Foetal death 139.49 9.96 165 217418 15880 110355836
Clostridium test positive 138.61 9.96 137 217446 10756 110360960
Vaginal flatulence 138.58 9.96 144 217439 12000 110359716
Procedural pain 135.84 9.96 248 217335 35317 110336399
Neutropenia 132.81 9.96 342 217241 374278 109997438
Drug intolerance 127.50 9.96 1291 216292 405221 109966495
Female genital tract fistula 124.39 9.96 158 217425 16361 110355355
Radiculopathy 122.59 9.96 170 217413 19166 110352550
Blood phosphorus increased 121.01 9.96 155 217428 16185 110355531
Abdominal pain 120.64 9.96 1540 216043 511449 109860267
Stress 120.59 9.96 468 217115 104880 110266836
Oedema 114.85 9.96 757 216826 209219 110162497
Myelosuppression 114.65 9.96 23 217560 94317 110277399
Neuralgia 113.78 9.96 277 217306 48201 110323515
Drug therapy 112.44 9.96 102 217481 7189 110364527
Proctitis 112.10 9.96 152 217431 16775 110354941
Macular degeneration 112.05 9.96 173 217410 21486 110350230
Acute kidney injury 111.48 9.96 762 216821 634668 109737048
Respiratory rate decreased 107.37 9.96 93 217490 6165 110365551
Intentional overdose 106.90 9.96 64 217519 132437 110239279
Intentional product misuse 105.39 9.96 529 217054 132375 110239341
Vaginal discharge 101.11 9.96 149 217434 17759 110353957
Chronic sinusitis 101.01 9.96 179 217404 24905 110346811
Sleep disorder therapy 100.75 9.96 97 217486 7374 110364342
Interstitial lung disease 99.45 9.96 77 217506 139257 110232459
Sleep disorder due to general medical condition, insomnia type 98.75 9.96 42 217541 105601 110266115
Incorrect route of product administration 96.92 9.96 312 217271 63749 110307967
Febrile neutropenia 96.87 9.96 1001 216582 315766 110055950
Unresponsive to stimuli 94.99 9.96 309 217274 63481 110308235
Myasthenia gravis 93.80 9.96 159 217424 21352 110350364
Nephrolithiasis 91.72 9.96 313 217270 65899 110305817
Myocardial infarction 91.30 9.96 148 217435 191935 110179781
Therapeutic product effect incomplete 89.96 9.96 750 216833 223055 110148661
Nightmare 89.01 9.96 220 217363 38643 110333073
Bursitis 88.55 9.96 496 217087 129422 110242294
Infusion site reaction 88.35 9.96 139 217444 17543 110354173
Hepatic cytolysis 87.96 9.96 5 217578 55048 110316668
Ankylosing spondylitis 86.86 9.96 129 217454 15483 110356233
Joint dislocation 84.15 9.96 199 217384 33991 110337725
Toxicologic test abnormal 83.52 9.96 44 217539 1263 110370453
Paraesthesia oral 80.73 9.96 194 217389 33477 110338239
Hypophosphataemia 80.44 9.96 192 217391 32990 110338726
Sinusitis 78.35 9.96 309 217274 296379 110075337
Exostosis 77.08 9.96 232 217351 45724 110325992
Drug reaction with eosinophilia and systemic symptoms 76.15 9.96 33 217550 82062 110289654
Hyperphosphataemia 75.33 9.96 124 217459 16257 110355459
Suicide attempt 75.24 9.96 56 217527 103338 110268378
Oral candidiasis 75.11 9.96 226 217357 44534 110327182
Product dose omission issue 74.66 9.96 352 217231 321430 110050286
Drug resistance 74.52 9.96 11 217572 56363 110315353
Fluid retention 74.49 9.96 375 217208 93932 110277784
Inadequate analgesia 74.35 9.96 69 217514 5008 110366708
Ascites 73.27 9.96 369 217214 92439 110279277
Medical device site pain 73.14 9.96 28 217555 367 110371349
Cardiac failure congestive 73.02 9.96 115 217468 150885 110220831
Cardiac failure 73.00 9.96 163 217420 187463 110184253
Victim of child abuse 72.41 9.96 39 217544 1172 110370544
Pruritus 72.37 9.96 763 216820 580797 109790919
Hepatic function abnormal 72.21 9.96 43 217540 89252 110282464
Rash erythematous 70.80 9.96 334 217249 81498 110290218
General physical health deterioration 69.71 9.96 1200 216383 424095 109947621
Agranulocytosis 69.16 9.96 18 217565 61742 110309974
Child abuse 68.64 9.96 34 217549 855 110370861
Blood uric acid increased 68.56 9.96 139 217444 21390 110350326
C-reactive protein abnormal 68.37 9.96 93 217490 129602 110242114
Alopecia 68.11 9.96 429 217154 364324 110007392
Ventricular fibrillation 66.89 9.96 206 217377 41107 110330609
Cardiogenic shock 65.82 9.96 255 217328 57083 110314633
Epidural lipomatosis 64.85 9.96 44 217539 2023 110369693
Cytomegalovirus infection 64.65 9.96 14 217569 54430 110317286
Lactic acidosis 64.08 9.96 53 217530 92758 110278958
Soft tissue disorder 63.78 9.96 54 217529 3470 110368246
Antacid therapy 62.52 9.96 65 217518 5419 110366297
Hepatic cirrhosis 60.69 9.96 279 217304 67347 110304369
Pneumonia viral 60.37 9.96 91 217492 11066 110360650
Upper respiratory tract infection 59.80 9.96 453 217130 130875 110240841
Rash 58.75 9.96 1201 216382 819763 109551953
Lower respiratory tract infection 58.72 9.96 262 217321 242844 110128872
COVID-19 58.65 9.96 265 217318 244795 110126921
Anticoagulant therapy 58.37 9.96 62 217521 5299 110366417
Neck pain 56.79 9.96 426 217157 122704 110249012
Extremity contracture 56.48 9.96 38 217545 1723 110369993
Arthropathy 54.78 9.96 336 217247 287186 110084530
Overdose 54.46 9.96 701 216882 233093 110138623
Bradycardia 54.26 9.96 143 217440 155374 110216342
Gastrointestinal haemorrhage 54.17 9.96 157 217426 165361 110206355
Delirium 53.96 9.96 452 217131 134573 110237143
Bone erosion 53.04 9.96 206 217377 46165 110325551
Iron deficiency 52.66 9.96 114 217469 18362 110353354
Blepharospasm 51.99 9.96 230 217353 54621 110317095
Cerebrovascular accident 51.62 9.96 183 217400 181101 110190615
Rhabdomyolysis 51.56 9.96 99 217484 120302 110251414
Foot deformity 51.15 9.96 210 217373 48270 110323446
Hypermobility syndrome 51.05 9.96 24 217559 536 110371180
Taste disorder 50.92 9.96 259 217324 65128 110306588
Hepatocellular injury 50.85 9.96 18 217565 50624 110321092
Orthostatic hypotension 50.68 9.96 34 217549 66215 110305501
Sickle cell anaemia with crisis 50.44 9.96 77 217506 9468 110362248
Retinitis 50.31 9.96 159 217424 32168 110339548
Opiates positive 49.96 9.96 28 217555 911 110370805
Gastrooesophageal reflux disease 49.96 9.96 558 217025 179418 110192298
Malaise 49.66 9.96 1699 215884 670120 109701596
Injection site swelling 49.61 9.96 30 217553 61760 110309956
Palpitations 49.25 9.96 155 217428 159057 110212659
Renal impairment 48.63 9.96 198 217385 188247 110183469
Tubulointerstitial nephritis 48.50 9.96 23 217560 54261 110317455
Malignant neoplasm progression 48.35 9.96 541 217042 174026 110197690
Cholestasis 48.17 9.96 34 217549 64484 110307232
Hepatitis 48.04 9.96 64 217519 89990 110281726
Postmortem blood drug level abnormal 48.00 9.96 24 217559 616 110371100
Breast cancer metastatic 47.90 9.96 82 217501 11099 110360617
Drug diversion 47.21 9.96 31 217552 1349 110370367
Decompression sickness 47.03 9.96 15 217568 109 110371607
Device expulsion 45.90 9.96 4 217579 30887 110340829
Bacterial infection 45.90 9.96 196 217387 45840 110325876
Respiratory tract infection 45.89 9.96 269 217314 71348 110300368
Infusion related reaction 45.38 9.96 1025 216558 380137 109991579
Narcotic bowel syndrome 45.37 9.96 18 217565 261 110371455
Terminal insomnia 44.21 9.96 34 217549 1904 110369812
Arthritis 43.12 9.96 512 217071 167074 110204642
Gastrointestinal disorder 42.89 9.96 289 217294 241663 110130053
Pneumonia 42.71 9.96 2121 215462 874593 109497123
Eosinophilia 42.64 9.96 31 217552 57905 110313811
Frequent bowel movements 42.46 9.96 263 217320 71127 110300589
Joint stiffness 42.07 9.96 251 217332 66992 110304724
Erythema 41.96 9.96 806 216777 290641 110081075
Pulmonary fibrosis 41.89 9.96 86 217497 101956 110269760
Rash pruritic 41.67 9.96 81 217502 97988 110273728
Renal failure 41.49 9.96 268 217315 226306 110145410
Alanine aminotransferase increased 41.45 9.96 203 217380 183570 110188146
Mechanical ventilation complication 41.05 9.96 23 217560 748 110370968
Neoplasm progression 40.98 9.96 242 217341 64353 110307363
Hyperkalaemia 40.75 9.96 134 217449 135662 110236054
Syncope 40.51 9.96 233 217350 202303 110169413
Postoperative ileus 40.35 9.96 27 217556 1213 110370503
Pneumonia aspiration 40.29 9.96 286 217297 80947 110290769
Mental status changes 40.11 9.96 272 217311 75850 110295866
Apnoeic attack 39.94 9.96 23 217560 789 110370927
Status epilepticus 39.84 9.96 7 217576 31564 110340152
Prescribed overdose 39.81 9.96 302 217281 87279 110284437
Implant site extravasation 39.65 9.96 24 217559 904 110370812
Injection site pruritus 39.62 9.96 26 217557 51232 110320484
Rash maculo-papular 39.33 9.96 53 217530 74169 110297547
Osteoporosis 39.32 9.96 300 217283 86852 110284864
Systemic lupus erythematosus 39.23 9.96 316 217267 254022 110117694
Dermatitis atopic 38.80 9.96 3 217580 25538 110346178
Poor venous access 38.51 9.96 121 217462 24401 110347315
Folliculitis 38.50 9.96 184 217399 167469 110204247
Ill-defined disorder 38.49 9.96 168 217415 156685 110215031
Pneumocystis jirovecii pneumonia 38.35 9.96 18 217565 42717 110328999
Wheezing 38.17 9.96 710 216873 254520 110117196
Abdominal distension 37.85 9.96 518 217065 174585 110197131
Drug ineffective for unapproved indication 37.81 9.96 338 217245 102500 110269216
Ischaemic stroke 37.61 9.96 17 217566 41246 110330470
Injection site pain 37.60 9.96 201 217382 177721 110193995
Melaena 37.56 9.96 48 217535 68709 110303007
Blood pressure systolic increased 37.06 9.96 285 217298 82706 110289010
Liver disorder 36.98 9.96 149 217434 142094 110229622
Laryngitis 36.60 9.96 173 217410 42238 110329478
Abortion spontaneous 36.51 9.96 11 217572 34271 110337445
Withdrawal syndrome 36.37 9.96 140 217443 31240 110340476
Chest injury 36.37 9.96 39 217544 3370 110368346
Duodenal ulcer perforation 36.31 9.96 203 217380 177497 110194219
Activated partial thromboplastin time prolonged 35.71 9.96 111 217472 22257 110349459
Myoclonus 35.65 9.96 144 217439 32854 110338862
Sepsis 35.49 9.96 869 216714 326477 110045239
Decreased immune responsiveness 35.44 9.96 66 217517 9540 110362176
Foreign body embolism 35.40 9.96 8 217575 10 110371706
Drug eruption 35.39 9.96 32 217551 53627 110318089
Extrapyramidal disorder 35.15 9.96 7 217576 28860 110342856
Eye irritation 35.15 9.96 11 217572 33441 110338275
Blood pressure increased 34.99 9.96 708 216875 257665 110114051
Basal cell carcinoma 34.94 9.96 23 217560 45247 110326469
Onychomycosis 34.93 9.96 16 217567 38515 110333201
Parkinsonism hyperpyrexia syndrome 34.45 9.96 19 217564 599 110371117
Diarrhoea 34.34 9.96 1863 215720 1137642 109234074
Juvenile idiopathic arthritis 33.94 9.96 50 217533 5957 110365759
Red blood cell sedimentation rate increased 33.37 9.96 266 217317 78036 110293680
Accidental death 33.20 9.96 45 217538 4964 110366752
Anaemia of malignant disease 33.16 9.96 22 217561 974 110370742
Back injury 32.97 9.96 182 217401 47217 110324499
Blood pressure fluctuation 32.88 9.96 256 217327 74568 110297148
Drug tolerance increased 32.31 9.96 18 217565 579 110371137
Pelvic pain 32.12 9.96 86 217497 15856 110355860
Hand deformity 32.09 9.96 275 217308 218231 110153485
Plasma cell myeloma 32.04 9.96 223 217360 62713 110309003
Systemic infection 31.98 9.96 64 217519 9755 110361961
Cerebral haemorrhage 31.86 9.96 49 217534 64919 110306797
Abdominal discomfort 31.83 9.96 564 217019 393294 109978422
Blister 31.71 9.96 290 217293 227086 110144630
Tenderness 31.44 9.96 128 217455 29309 110342407
Postmortem blood drug level increased 31.43 9.96 23 217560 1194 110370522
Product used for unknown indication 31.33 9.96 28 217555 1935 110369781
Headache 31.03 9.96 2073 215510 880304 109491412
Bone marrow failure 30.97 9.96 41 217542 57807 110313909
Drug tolerance 30.95 9.96 87 217496 16498 110355218
Cerebral infarction 30.65 9.96 34 217549 51804 110319912
Sopor 30.40 9.96 17 217566 36529 110335187
Dysphonia 30.23 9.96 254 217329 75675 110296041
Hypoglycaemia 29.94 9.96 122 217461 115982 110255734
Overwork 29.83 9.96 9 217574 53 110371663
Overlap syndrome 29.45 9.96 59 217524 9000 110362716
Drug abuse 29.16 9.96 501 217082 176910 110194806
Device related thrombosis 29.10 9.96 35 217548 3427 110368289
Hepatotoxicity 29.04 9.96 50 217533 63350 110308366
Septic shock 29.00 9.96 186 217397 157342 110214374
Small intestinal obstruction 28.97 9.96 133 217450 32080 110339636
Lymphopenia 28.91 9.96 22 217561 40148 110331568
Cryopyrin associated periodic syndrome 28.88 9.96 17 217566 608 110371108
Post cholecystectomy syndrome 28.81 9.96 19 217564 833 110370883
Lupus-like syndrome 28.62 9.96 157 217426 40635 110331081
Acute myocardial infarction 28.49 9.96 78 217505 83699 110288017
White blood cell count decreased 28.45 9.96 301 217282 229089 110142627
Visual acuity reduced 28.18 9.96 14 217569 32159 110339557
Irritable bowel syndrome 28.17 9.96 198 217385 164017 110207699
Platelet count decreased 27.93 9.96 304 217279 230139 110141577
Blood pressure diastolic increased 27.90 9.96 91 217492 18716 110353000
Dysgeusia 27.87 9.96 60 217523 69925 110301791
Acute chest syndrome 27.78 9.96 27 217556 2076 110369640
Post-traumatic stress disorder 27.76 9.96 48 217535 6548 110365168
Red blood cell sedimentation rate abnormal 27.72 9.96 7 217576 24502 110347214
Xyphoid retraction 27.57 9.96 11 217572 162 110371554
Pregnancy 27.53 9.96 36 217547 51031 110320685
Food aversion 27.20 9.96 24 217559 1631 110370085
Dyspnoea exertional 27.05 9.96 109 217474 103951 110267765
Road traffic accident 26.98 9.96 114 217469 107284 110264432
Congenital hiatus hernia 26.94 9.96 46 217537 6213 110365503
Swollen tongue 26.79 9.96 207 217376 60155 110311561
Nail bed inflammation 26.70 9.96 26 217557 2004 110369712
Rhesus antigen positive 26.62 9.96 10 217573 124 110371592
Blood test abnormal 26.51 9.96 119 217464 28435 110343281
Condition aggravated 26.45 9.96 1179 216404 733657 109638059
Nasal mucosal disorder 26.44 9.96 25 217558 1858 110369858
Blood creatine phosphokinase increased 26.40 9.96 66 217517 73011 110298705
Atrial fibrillation 26.23 9.96 307 217276 229335 110142381
Neurotoxicity 26.05 9.96 157 217426 42050 110329666
Haematotoxicity 25.90 9.96 5 217578 21077 110350639
Apnoea 25.90 9.96 72 217511 13567 110358149
Aspergillus infection 25.90 9.96 9 217574 25607 110346109
Tumour fistulisation 25.79 9.96 10 217573 136 110371580
Lung opacity 25.67 9.96 65 217518 11587 110360129
Drug tolerance decreased 25.65 9.96 11 217572 27529 110344187
Aspartate aminotransferase increased 25.44 9.96 197 217386 159739 110211977
Pancreatitis acute 25.42 9.96 50 217533 60224 110311492
Prostate cancer 25.36 9.96 22 217561 37619 110334097
Bacteroides infection 25.34 9.96 30 217553 2889 110368827
Granulocyte count increased 25.34 9.96 25 217558 1958 110369758
Colitis 25.17 9.96 310 217273 102013 110269703
Electric shock 25.15 9.96 24 217559 1804 110369912
Schizophrenia 25.14 9.96 6 217577 21820 110349896
Intentional self-injury 25.07 9.96 22 217561 37407 110334309
Injection site erythema 24.89 9.96 98 217485 94078 110277638
Eye pruritus 24.83 9.96 17 217566 32758 110338958
Device failure 24.71 9.96 48 217535 7159 110364557
Psychomotor hyperactivity 24.51 9.96 5 217578 20272 110351444
International normalised ratio increased 24.42 9.96 88 217495 86684 110285032
Disease recurrence 24.30 9.96 52 217531 60732 110310984
Administration site bruise 24.28 9.96 11 217572 225 110371491
Pemphigus 24.07 9.96 288 217295 214282 110157434
Therapy interrupted 24.02 9.96 38 217545 49784 110321932
Pulmonary hypertension 23.99 9.96 45 217538 55175 110316541
Total lung capacity decreased 23.93 9.96 47 217536 7067 110364649
Urinary tract disorder 23.91 9.96 42 217541 5802 110365914
Hypothermia 23.72 9.96 11 217572 26291 110345425
Drug ineffective 23.67 9.96 3373 214210 1517167 108854549
Helicobacter infection 23.64 9.96 236 217347 181641 110190075
Injection site urticaria 23.60 9.96 3 217580 17212 110354504
Muscle injury 23.56 9.96 171 217412 140636 110231080
Drug-induced liver injury 23.54 9.96 139 217444 119928 110251788
Ligament pain 23.51 9.96 11 217572 243 110371473
No adverse event 23.46 9.96 71 217512 73768 110297948
End stage renal disease 23.43 9.96 94 217489 21379 110350337
Eyelid injury 23.34 9.96 10 217573 178 110371538
Tumour pain 23.33 9.96 29 217554 2938 110368778
Anaesthetic complication neurological 23.29 9.96 18 217565 1015 110370701
Sciatica 23.26 9.96 98 217485 92301 110279415
Pericarditis 23.11 9.96 298 217285 218816 110152900
Lip dry 22.88 9.96 110 217473 99973 110271743
Metastases to bone 22.86 9.96 122 217461 31250 110340466
Amputation stump pain 22.82 9.96 7 217576 44 110371672
Rhinitis allergic 22.56 9.96 4 217579 17918 110353798
Chronic kidney disease 22.39 9.96 76 217507 76215 110295501
Fatigue 22.38 9.96 2725 214858 1213233 109158483
Alveolitis 22.32 9.96 35 217548 4404 110367312
Osteoarthritis 22.30 9.96 493 217090 182130 110189586
Platelet aggregation inhibition 22.28 9.96 10 217573 200 110371516
Contusion 22.23 9.96 324 217259 233037 110138679
Weight decreased 22.22 9.96 1130 216453 466927 109904789
Swollen joint count increased 22.14 9.96 87 217496 83574 110288142
Pulmonary arterial hypertension 21.98 9.96 19 217564 32549 110339167
Epstein-Barr virus infection 21.88 9.96 5 217578 18733 110352983
Cardiac failure acute 21.82 9.96 10 217573 24068 110347648
Scar 21.81 9.96 78 217505 16803 110354913
Multiple sclerosis relapse 21.77 9.96 41 217542 50199 110321517
Escherichia bacteraemia 21.67 9.96 56 217527 10108 110361608
Seasonal allergy 21.61 9.96 6 217577 19716 110352000
Obstructive airways disorder 21.50 9.96 36 217547 46113 110325603
Streptococcal sepsis 21.47 9.96 37 217546 5035 110366681
Metabolic acidosis 21.44 9.96 112 217471 99632 110272084
Inappropriate antidiuretic hormone secretion 21.37 9.96 21 217562 33830 110337886
Product storage error 21.35 9.96 8 217575 21720 110349996
Conjunctivitis 21.29 9.96 21 217562 33771 110337945
Inappropriate schedule of product administration 21.28 9.96 538 217045 203099 110168617
Endoscopic retrograde cholangiopancreatography 21.24 9.96 10 217573 224 110371492
Acute generalised exanthematous pustulosis 21.24 9.96 8 217575 21656 110350060
Oxygen therapy 21.24 9.96 33 217550 4120 110367596
Glossodynia 21.23 9.96 308 217275 221696 110150020
Varicose vein 21.14 9.96 44 217539 6896 110364820
Colitis ulcerative 21.06 9.96 239 217344 77124 110294592
Vitamin B12 increased 21.03 9.96 23 217560 2032 110369684
Skin necrosis 21 9.96 8 217575 21504 110350212
Arachnoiditis 20.98 9.96 17 217566 1027 110370689
Urticaria thermal 20.82 9.96 13 217570 518 110371198
Allodynia 20.77 9.96 23 217560 2060 110369656
Haematochezia 20.73 9.96 331 217252 115193 110256523
Photophobia 20.71 9.96 103 217480 25668 110346048
Biliary tract infection 20.68 9.96 21 217562 1703 110370013
Bronchopulmonary aspergillosis 20.68 9.96 17 217566 29846 110341870
Mitral valve incompetence 20.67 9.96 21 217562 33308 110338408
Ventricular tachycardia 20.65 9.96 42 217541 49967 110321749
Infusion site mass 20.64 9.96 21 217562 1707 110370009
Respiratory arrest 20.61 9.96 190 217393 58109 110313607
Circulatory collapse 20.53 9.96 33 217550 42960 110328756
Hypoaesthesia 20.53 9.96 784 216799 313439 110058277
Basal ganglion degeneration 20.52 9.96 12 217571 424 110371292
Blood immunoglobulin A increased 20.47 9.96 20 217563 1548 110370168
Liver injury 20.46 9.96 193 217390 150220 110221496
Administration site erythema 20.44 9.96 12 217571 427 110371289
Secondary amyloidosis 20.26 9.96 11 217572 336 110371380
Abdominal pain lower 20.10 9.96 134 217449 37149 110334567
Mucosal inflammation 20.09 9.96 109 217474 96032 110275684
Head banging 20.02 9.96 13 217570 555 110371161
Tricuspid valve incompetence 20.01 9.96 11 217572 23862 110347854
Hypocalcaemia 19.95 9.96 64 217519 65302 110306414
Aspartate aminotransferase 19.94 9.96 16 217567 953 110370763
Eczema 19.89 9.96 74 217509 72219 110299497
Impaired healing 19.84 9.96 270 217313 196447 110175269
Lip swelling 19.71 9.96 44 217539 50623 110321093
Skin exfoliation 19.65 9.96 97 217486 87554 110284162
Chest discomfort 19.62 9.96 233 217350 173615 110198101
Immune reconstitution inflammatory syndrome 19.62 9.96 4 217579 16222 110355494
Poisoning deliberate 19.49 9.96 14 217569 26317 110345399
Substance dependence 19.40 9.96 14 217569 711 110371005
Swelling 19.35 9.96 534 217049 350507 110021209
Blood glucose increased 19.34 9.96 167 217416 132329 110239387
Anuria 19.29 9.96 12 217571 24329 110347387
Product use issue 19.26 9.96 773 216810 310922 110060794
Hereditary angioedema 19.26 9.96 43 217540 7071 110364645
Sinus congestion 19.11 9.96 19 217564 30440 110341276
Heart rate increased 19.08 9.96 393 217190 143441 110228275
C-reactive protein 18.93 9.96 19 217564 30312 110341404
Drug level increased 18.92 9.96 41 217542 47678 110324038
Tissue infiltration 18.91 9.96 16 217567 1027 110370689
Electrocardiogram QT prolonged 18.87 9.96 131 217452 108829 110262887
Product substitution issue 18.79 9.96 11 217572 23050 110348666
Hypertensive encephalopathy 18.79 9.96 17 217566 1194 110370522
Neutrophil count decreased 18.75 9.96 150 217433 120791 110250925
Type IIa hyperlipidaemia 18.74 9.96 12 217571 500 110371216
Labelled drug-drug interaction medication error 18.70 9.96 18 217565 29284 110342432
Coronary artery disease 18.69 9.96 75 217508 71615 110300101
Oral pain 18.66 9.96 132 217451 37312 110334404
Glomerular filtration rate increased 18.58 9.96 21 217562 1924 110369792
Troponin increased 18.55 9.96 111 217472 29655 110342061
Contraindicated product administered 18.31 9.96 628 216955 247639 110124077
Body temperature decreased 18.29 9.96 130 217453 36805 110334911
Prostate cancer metastatic 18.28 9.96 34 217549 4909 110366807
Asphyxia 18.27 9.96 3 217580 14212 110357504
Hyperbilirubinaemia 18.26 9.96 20 217563 30651 110341065
Pathogen resistance 18.23 9.96 6 217577 17666 110354050
Deep vein thrombosis postoperative 18.13 9.96 58 217525 59233 110312483
Aggression 18.05 9.96 58 217525 59152 110312564
Stevens-Johnson syndrome 18.02 9.96 41 217542 46860 110324856
Implant site pain 17.98 9.96 22 217561 2193 110369523
Calcinosis 17.97 9.96 25 217558 2827 110368889
Hemianopia 17.86 9.96 25 217558 2843 110368873
Aspiration 17.85 9.96 112 217471 30421 110341295
Seizure like phenomena 17.83 9.96 23 217560 2418 110369298
Sinus bradycardia 17.80 9.96 19 217564 29464 110342252
Rheumatoid factor negative 17.76 9.96 17 217566 1283 110370433
Tenosynovitis 17.75 9.96 5 217578 16278 110355438
Myelodysplastic syndrome 17.69 9.96 29 217554 37455 110334261
Cholangitis infective 17.58 9.96 14 217569 825 110370891
Aortic stenosis 17.44 9.96 61 217522 12998 110358718
Accidental exposure to product 17.42 9.96 46 217537 49962 110321754
Malignant polyp 17.38 9.96 8 217575 170 110371546
Blood calcium increased 17.36 9.96 76 217507 17964 110353752
Hypersensitivity 17.30 9.96 966 216617 403032 109968684
Device power source issue 17.14 9.96 17 217566 1340 110370376
Intestinal obstruction 17.09 9.96 170 217413 53057 110318659
Diabetes mellitus inadequate control 17.09 9.96 20 217563 29755 110341961
Transplant rejection 16.99 9.96 14 217569 24553 110347163
Sleep disorder 16.86 9.96 511 217072 198133 110173583
Osteonecrosis of jaw 16.86 9.96 44 217539 47973 110323743
Micrococcus infection 16.80 9.96 8 217575 184 110371532
Diabetic ketoacidosis 16.79 9.96 36 217547 42022 110329694
Purpura 16.74 9.96 14 217569 24374 110347342
Intensive care 16.73 9.96 22 217561 2357 110369359
Tuberculosis 16.71 9.96 7 217576 17767 110353949
Device infusion issue 16.71 9.96 25 217558 3020 110368696
Cytomegalovirus viraemia 16.70 9.96 7 217576 17757 110353959
Antidepressant drug level above therapeutic 16.66 9.96 13 217570 744 110370972
Therapy non-responder 16.56 9.96 214 217369 157093 110214623
Lower limb fracture 16.54 9.96 84 217499 75264 110296452
Pseudomonal sepsis 16.44 9.96 47 217536 8999 110362717
Bacillus infection 16.40 9.96 18 217565 1596 110370120
Neuroleptic malignant syndrome 16.40 9.96 26 217557 34033 110337683
Anaphylactic reaction 16.39 9.96 316 217267 113984 110257732
Myocardial ischaemia 16.33 9.96 17 217566 26667 110345049
Compartment syndrome 16.31 9.96 36 217547 5874 110365842
Tumour perforation 16.23 9.96 12 217571 633 110371083
Rib fracture 16.22 9.96 118 217465 33652 110338064
Red cell distribution width increased 16.07 9.96 73 217510 17529 110354187
Urticaria 16.07 9.96 491 217092 318366 110053350
Shock 15.99 9.96 53 217530 53535 110318181
Iritis 15.97 9.96 31 217552 4621 110367095
Injection site reaction 15.97 9.96 106 217477 88964 110282752
Acute graft versus host disease 15.94 9.96 3 217580 12878 110358838
Personality disorder 15.87 9.96 3 217580 12834 110358882
Forced expiratory flow decreased 15.84 9.96 9 217574 301 110371415
Weight increased 15.75 9.96 670 216913 418974 109952742
Adiposis dolorosa 15.73 9.96 9 217574 305 110371411
Pancytopenia 15.72 9.96 304 217279 209309 110162407
Granulocytopenia 15.66 9.96 3 217580 12712 110359004
Kidney infection 15.65 9.96 95 217488 25504 110346212
Grip strength decreased 15.61 9.96 93 217490 80081 110291635
Limb mass 15.56 9.96 28 217555 3941 110367775
Bronchopulmonary aspergillosis allergic 15.53 9.96 44 217539 8382 110363334
Caesarean section 15.52 9.96 4 217579 13813 110357903
Psychotic disorder 15.46 9.96 50 217533 50887 110320829
Ataxia 15.45 9.96 22 217561 30086 110341630
Transitional cell carcinoma metastatic 15.37 9.96 7 217576 145 110371571
Occipital neuralgia 15.30 9.96 12 217571 692 110371024
Device difficult to use 15.28 9.96 9 217574 18796 110352920
Failure to thrive 15.28 9.96 60 217523 13514 110358202
Infective pulmonary exacerbation of cystic fibrosis 15.26 9.96 5 217578 14766 110356950
Antasthmatic drug level 15.26 9.96 5 217578 40 110371676
Neutropenic sepsis 15.25 9.96 23 217560 30723 110340993
Pemphigoid 15.22 9.96 10 217573 19697 110352019
Disseminated intravascular coagulation 15.14 9.96 37 217546 41249 110330467
Dysarthria 15.13 9.96 100 217483 84021 110287695
Dry skin 15.13 9.96 137 217446 107516 110264200
Tardive dyskinesia 15.12 9.96 4 217579 13575 110358141
Knee arthroplasty 15.07 9.96 71 217512 64877 110306839
Jaundice cholestatic 15.00 9.96 5 217578 14603 110357113
Fear of disease 14.95 9.96 16 217567 1379 110370337
Microembolism 14.94 9.96 5 217578 43 110371673
Screaming 14.93 9.96 31 217552 4850 110366866
Parkinsonism 14.91 9.96 13 217570 22174 110349542
Serotonin syndrome 14.89 9.96 180 217403 58973 110312743
Sleep deficit 14.87 9.96 18 217565 1774 110369942
Palmar-plantar erythrodysaesthesia syndrome 14.86 9.96 37 217546 40988 110330728
Cardiomyopathy 14.85 9.96 27 217556 33498 110338218
Death 14.81 9.96 1581 216002 697288 109674428
Blood pressure diastolic decreased 14.79 9.96 121 217462 35764 110335952
Thrombosis 14.77 9.96 298 217285 108364 110263352
Analgesic drug level 14.74 9.96 5 217578 45 110371671
Cardiac murmur 14.73 9.96 16 217567 24612 110347104
Anaesthesia 14.67 9.96 11 217572 593 110371123
Proteus test positive 14.65 9.96 12 217571 736 110370980
Spinal shock 14.64 9.96 5 217578 46 110371670
Joint range of motion decreased 14.64 9.96 161 217422 121671 110250045
Product prescribing error 14.62 9.96 160 217423 51171 110320545
Transfusion 14.62 9.96 93 217490 25379 110346337
Mixed liver injury 14.56 9.96 3 217580 12076 110359640
Angina pectoris 14.51 9.96 68 217515 62227 110309489
Hypogammaglobulinaemia 14.44 9.96 11 217572 20065 110351651
Motor dysfunction 14.44 9.96 16 217567 24390 110347326
Medication error 14.41 9.96 135 217448 105231 110266485
Hyperthyroidism 14.41 9.96 22 217561 29239 110342477
Atrioventricular block first degree 14.38 9.96 5 217578 14220 110357496
Ventricular extrasystoles 14.34 9.96 14 217569 22627 110349089
Scratch 14.31 9.96 57 217526 12922 110358794
Injury 14.25 9.96 254 217329 177011 110194705
Injection site rash 14.25 9.96 15 217568 23404 110348312
Liver function test increased 14.16 9.96 249 217334 88299 110283417
Painful respiration 14.14 9.96 26 217557 3721 110367995
Stomatitis 14.14 9.96 414 217169 269828 110101888
Blood pressure diastolic abnormal 14.05 9.96 93 217490 25722 110345994
Skin toxicity 14.05 9.96 3 217580 11780 110359936
Loss of personal independence in daily activities 14.03 9.96 209 217374 149811 110221905
Vascular device infection 13.99 9.96 67 217516 16445 110355271
Hypercapnia 13.94 9.96 51 217532 11108 110360608
Hyperglycaemia 13.91 9.96 104 217479 84986 110286730
Oxygen saturation decreased 13.91 9.96 406 217177 156576 110215140
Atrioventricular septal defect 13.89 9.96 6 217577 109 110371607
Miliaria 13.82 9.96 18 217565 1911 110369805
Nephrotic syndrome 13.74 9.96 5 217578 13826 110357890
Cardiac failure chronic 13.71 9.96 5 217578 13806 110357910
Ocular procedural complication 13.70 9.96 10 217573 517 110371199
Uterine enlargement 13.68 9.96 13 217570 972 110370744
Labelled drug-drug interaction issue 13.68 9.96 27 217556 4074 110367642
Hypercholesterolaemia 13.67 9.96 253 217330 90584 110281132
Hyperthermia 13.66 9.96 13 217570 21259 110350457
Fistula 13.63 9.96 63 217520 15236 110356480
Seizure 13.63 9.96 331 217252 220854 110150862
Silicon granuloma 13.63 9.96 3 217580 3 110371713
Pustular psoriasis 13.62 9.96 58 217525 13547 110358169
Prostate examination abnormal 13.51 9.96 7 217576 194 110371522
Bladder cancer 13.50 9.96 12 217571 20280 110351436
Spinal cord compression 13.49 9.96 39 217544 7513 110364203
Nervousness 13.48 9.96 121 217462 36730 110334986
Medication overuse headache 13.46 9.96 16 217567 1547 110370169
Impaired quality of life 13.45 9.96 24 217559 29993 110341723
Ileus 13.42 9.96 105 217478 30624 110341092
Hypomagnesaemia 13.42 9.96 67 217516 60303 110311413
Rash papular 13.40 9.96 21 217562 27618 110344098
Dermatitis bullous 13.40 9.96 9 217574 17520 110354196
C-reactive protein increased 13.35 9.96 540 217043 217379 110154337
Dry mouth 13.32 9.96 500 217083 199448 110172268
Arthritis infective 13.31 9.96 48 217535 10381 110361335
Febrile bone marrow aplasia 13.31 9.96 9 217574 17456 110354260
Klebsiella test positive 13.30 9.96 20 217563 2426 110369290
Dysphoria 13.28 9.96 35 217548 6393 110365323
Central nervous system lesion 13.28 9.96 7 217576 15546 110356170
Product dose omission in error 13.28 9.96 16 217567 23496 110348220
Radiation necrosis 13.27 9.96 12 217571 842 110370874
Hypertransaminasaemia 13.18 9.96 17 217566 24238 110347478
Angina unstable 13.16 9.96 8 217575 16424 110355292
Transient ischaemic attack 13.11 9.96 73 217510 63909 110307807
Dystonia 13.10 9.96 19 217564 25786 110345930
Oxygen saturation abnormal 13.10 9.96 32 217551 5579 110366137
Administration related reaction 13.08 9.96 8 217575 307 110371409
Vision blurred 13.04 9.96 177 217406 128845 110242871
Ulcer 13.03 9.96 136 217447 42980 110328736
Infusion site mobility decreased 13.03 9.96 5 217578 66 110371650
Blood immunoglobulin M decreased 13.02 9.96 18 217565 2023 110369693
Cystitis haemorrhagic 12.85 9.96 4 217579 12205 110359511
Anaphylactic shock 12.77 9.96 55 217528 51491 110320225
Nasal polyps 12.73 9.96 5 217578 13195 110358521
Gastric cancer 12.73 9.96 3 217580 11005 110360711
Eye swelling 12.61 9.96 29 217554 33019 110338697
Hepatitis acute 12.60 9.96 11 217572 18755 110352961
Bone pain 12.59 9.96 189 217394 64944 110306772
Pulmonary embolism 12.58 9.96 529 217054 213945 110157771
Normochromic normocytic anaemia 12.51 9.96 5 217578 13052 110358664
Swelling face 12.49 9.96 253 217330 92068 110279648
Jaundice 12.46 9.96 67 217516 59169 110312547
Atrioventricular block 12.46 9.96 9 217574 16868 110354848
Thrombotic microangiopathy 12.45 9.96 24 217559 29125 110342591
Abdominal tenderness 12.39 9.96 53 217530 12404 110359312
Arrhythmia 12.37 9.96 83 217500 69492 110302224
Bradykinesia 12.36 9.96 3 217580 10785 110360931
Erectile dysfunction 12.31 9.96 11 217572 18545 110353171
Erythema multiforme 12.29 9.96 14 217569 21083 110350633
Heart rate irregular 12.26 9.96 112 217471 34162 110337554
Amaurosis fugax 12.23 9.96 19 217564 2371 110369345
Endotracheal intubation 12.23 9.96 33 217550 6111 110365605
Product label confusion 12.21 9.96 16 217567 22661 110349055
Vaginal haemorrhage 12.21 9.96 19 217564 25055 110346661
Creatinine renal clearance decreased 12.15 9.96 15 217568 21800 110349916
Spinal pain 12.15 9.96 70 217513 18445 110353271
Low density lipoprotein increased 12.15 9.96 3 217580 10663 110361053
CFTR gene mutation 12.11 9.96 7 217576 242 110371474
Administration site swelling 12.10 9.96 10 217573 621 110371095
Mucormycosis 12.09 9.96 3 217580 10625 110361091
Dyskinesia 12.08 9.96 56 217527 51390 110320326
Rubber sensitivity 12.07 9.96 19 217564 2399 110369317
Insurance issue 12.06 9.96 3 217580 10609 110361107
Eye operation 12.01 9.96 20 217563 2647 110369069
Irregular breathing 11.97 9.96 10 217573 631 110371085
Groin pain 11.93 9.96 61 217522 15367 110356349
Burning sensation 11.93 9.96 197 217386 69015 110302701
Wrong technique in product usage process 11.91 9.96 112 217471 87236 110284480
Breast pain 11.91 9.96 45 217538 9955 110361761
Finger deformity 11.87 9.96 30 217553 33062 110338654
Hepatic enzyme increased 11.78 9.96 757 216826 320135 110051581
Post procedural pulmonary embolism 11.78 9.96 7 217576 255 110371461
Blood triglycerides increased 11.77 9.96 18 217565 23908 110347808
Rheumatoid factor positive 11.77 9.96 185 217398 131455 110240261
Fasciotomy 11.67 9.96 5 217578 89 110371627
Pain assessment 11.60 9.96 4 217579 38 110371678
Nephropathy 11.59 9.96 6 217577 13461 110358255
Rheumatoid factor increased 11.57 9.96 19 217564 2486 110369230
Deafness 11.40 9.96 22 217561 26687 110345029
Rheumatic fever 11.39 9.96 171 217412 122408 110249308
Adjustment disorder with depressed mood 11.38 9.96 46 217537 43837 110327879
Eyelid ptosis 11.37 9.96 6 217577 13321 110358395
Rubella 11.36 9.96 6 217577 173 110371543
Brain oedema 11.32 9.96 102 217481 30996 110340720
Anti-cyclic citrullinated peptide antibody positive 11.30 9.96 272 217311 181712 110190004
Cholangitis sclerosing 11.25 9.96 23 217560 3559 110368157
Brain natriuretic peptide increased 11.23 9.96 4 217579 11205 110360511
Alpha haemolytic streptococcal infection 11.20 9.96 23 217560 3570 110368146
Psoriatic arthropathy 11.17 9.96 298 217285 196463 110175253
Infusion site granuloma 11.10 9.96 3 217580 11 110371705
Rhinitis 11.06 9.96 17 217566 22528 110349188
Post procedural complication 11.05 9.96 90 217493 26568 110345148
Umbilical discharge 11.00 9.96 5 217578 103 110371613
Palliative care 10.99 9.96 15 217568 1665 110370051
Communication disorder 10.99 9.96 28 217555 5011 110366705
Hepatic steatosis 10.97 9.96 54 217529 48777 110322939
Withdrawal hypertension 10.94 9.96 8 217575 415 110371301
Visual impairment 10.92 9.96 344 217239 134084 110237632
Electrocardiogram QRS complex prolonged 10.91 9.96 6 217577 13015 110358701
Adenovirus infection 10.88 9.96 4 217579 10990 110360726
Aortic valve incompetence 10.86 9.96 4 217579 10977 110360739
Medical device site infection 10.85 9.96 10 217573 719 110370997
Diabetes mellitus 10.80 9.96 264 217319 99117 110272599
Product contamination microbial 10.77 9.96 12 217571 1082 110370634
Postoperative delirium 10.71 9.96 11 217572 904 110370812
Blindness unilateral 10.68 9.96 3 217580 9783 110361933
Vitamin K deficiency 10.65 9.96 11 217572 910 110370806
Treatment noncompliance 10.65 9.96 92 217491 72898 110298818
Mental disorder 10.63 9.96 120 217463 38671 110333045
Coronary artery stenosis 10.60 9.96 7 217576 13751 110357965
Delirium tremens 10.60 9.96 10 217573 741 110370975
Neuropathy peripheral 10.58 9.96 270 217313 179007 110192709
Cholecystitis acute 10.58 9.96 60 217523 15722 110355994
Blood urea increased 10.57 9.96 64 217519 54893 110316823
Metastases to central nervous system 10.54 9.96 79 217504 22738 110348978
Device computer issue 10.50 9.96 5 217578 115 110371601
Clostridium difficile colitis 10.49 9.96 132 217451 43646 110328070
Arteriosclerosis coronary artery 10.45 9.96 21 217562 25097 110346619
Behaviour disorder 10.45 9.96 3 217580 9644 110362072
Implant site haematoma 10.44 9.96 6 217577 205 110371511
Tooth abscess 10.41 9.96 68 217515 18721 110352995
Bronchospasm 10.39 9.96 28 217555 30211 110341505
Eosinophilic granulomatosis with polyangiitis 10.39 9.96 4 217579 10682 110361034
Rash macular 10.38 9.96 40 217543 38646 110333070
Eyelid haematoma 10.35 9.96 5 217578 119 110371597
Aplasia pure red cell 10.33 9.96 3 217580 9575 110362141
Carotid artery occlusion 10.31 9.96 3 217580 9562 110362154
Oesophageal infection 10.30 9.96 10 217573 768 110370948
Respiratory tract congestion 10.29 9.96 29 217554 30828 110340888
Myopathy 10.27 9.96 21 217562 24939 110346777
Autoimmune disorder 10.25 9.96 81 217502 65402 110306314
Sarcoidosis 10.25 9.96 6 217577 12573 110359143
Haematuria 10.25 9.96 109 217474 82896 110288820
Streptococcal bacteraemia 10.24 9.96 26 217557 4643 110367073
Discomfort 10.24 9.96 333 217250 214374 110157342
Spinal disorder 10.23 9.96 48 217535 11680 110360036
Onychomadesis 10.23 9.96 136 217447 45527 110326189
Hip arthroplasty 10.22 9.96 66 217517 55747 110315969
Breakthrough pain 10.21 9.96 14 217569 1562 110370154
Retinal haemorrhage 10.21 9.96 3 217580 9498 110362218
Affect lability 10.19 9.96 13 217570 18624 110353092
Burkholderia test positive 10.16 9.96 9 217574 615 110371101
Injection site mass 10.15 9.96 83 217500 24530 110347186
Fluid replacement 10.15 9.96 11 217572 962 110370754
Skin haemorrhage 10.12 9.96 21 217562 24806 110346910
Colorectal cancer metastatic 10.12 9.96 14 217569 1575 110370141
Anosmia 10.09 9.96 6 217577 12466 110359250
Device kink 10.09 9.96 16 217567 2033 110369683
Liver iron concentration abnormal 10.08 9.96 4 217579 58 110371658
Colitis microscopic 10.07 9.96 7 217576 13387 110358329
Pulmonary alveolar haemorrhage 10.07 9.96 15 217568 20135 110351581
Organising pneumonia 10.00 9.96 8 217575 14235 110357481
Sneezing 9.98 9.96 31 217552 31953 110339763
Gout 9.97 9.96 113 217470 36453 110335263
Hot flush 9.96 9.96 184 217399 65852 110305864

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N02AA03 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Natural opium alkaloids
ATC N02AA53 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Natural opium alkaloids
ATC N02AG04 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with antispasmodics
MeSH PA D000700 Analgesics
MeSH PA D000701 Analgesics, Opioid
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D009294 Narcotics
MeSH PA D018689 Sensory System Agents
CHEBI has role CHEBI:35482 opioid analgesic
CHEBI has role CHEBI:55322 ฮผ-opioid receptor agonist
FDA MoA N0000175684 Full Opioid Agonists
FDA EPC N0000175690 Opioid Agonist

Related Drugs by ATC class:

N02AA Natural opium alkaloids 8 drugs
codeinedihydrocodeinemorphinenaloxonenaltrexonenicomorphineoxycodoneoxymorphone
N02AG Opioids in combination with antispasmodics 3 drugs
ketobemidonemorphinepethidine

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Pain indication 22253000
Cough indication 49727002
Severe pain indication 76948002
Common cold indication 82272006 DOID:10459
Acute postoperative pain indication 107401000119105
Chronic Pain with Opioid Tolerance indication
Severe Pain with Opioid Tolerance indication
Suicidal thoughts contraindication 6471006
Dependent drug abuse contraindication 6525002
Alcohol withdrawal delirium contraindication 8635005
Asthenia contraindication 13791008
Constipation contraindication 14760008 DOID:2089
Mood swings contraindication 18963009
Inflammatory bowel disease contraindication 24526004 DOID:0050589
Alcohol intoxication contraindication 25702006
Complete atrioventricular block contraindication 27885002
Shock contraindication 27942005
Hypercapnia contraindication 29596007
Dehydration contraindication 34095006
Disorder of gallbladder contraindication 39621005 DOID:0060262
Hypothyroidism contraindication 40930008 DOID:1459
Conduction disorder of the heart contraindication 44808001
Low blood pressure contraindication 45007003
Bradycardia contraindication 48867003
Paralytic ileus contraindication 55525008 DOID:8442
Hepatic failure contraindication 59927004
Ulcerative colitis contraindication 64766004 DOID:8577
Substance abuse contraindication 66214007
Benign intracranial hypertension contraindication 68267002 DOID:11459
Urethral stricture contraindication 76618002
Decreased respiratory function contraindication 80954004
Injury of head contraindication 82271004
Cor pulmonale contraindication 83291003 DOID:8515
Pulmonary emphysema contraindication 87433001
Kidney disease contraindication 90708001 DOID:557
Acute abdominal pain contraindication 116290004
Neoplasm of brain contraindication 126952004 DOID:1319
Seizure disorder contraindication 128613002
Drug-induced psychosis contraindication 191483003 DOID:1742
Disease of liver contraindication 235856003 DOID:409
Morbid obesity contraindication 238136002 DOID:11981
Sepsis syndrome contraindication 238150007
Benign prostatic hyperplasia contraindication 266569009
Retention of urine contraindication 267064002
Exacerbation of asthma contraindication 281239006
Lesion of brain contraindication 301766008
Deficiency of cholinesterase contraindication 360607009
Coma contraindication 371632003
Primary adrenocortical insufficiency contraindication 373662000
Operation on gastrointestinal tract contraindication 386621005
Hypoxia contraindication 389086002
Central nervous system depression contraindication 418072004
Dysfunction of sphincter of Oddi contraindication 430887001




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.67 acidic
pKa2 8.64 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Mu-type opioid receptor GPCR AGONIST Ki 9.55 CHEMBL CHEMBL
Kappa-type opioid receptor GPCR Ki 8.55 CHEMBL
Delta-type opioid receptor GPCR Ki 7.42 CHEMBL
Opioid receptor GPCR EC50 9 CHEMBL

External reference:

IDSource
4019779 VUID
N0000147870 NUI
D00839 KEGG_DRUG
71-68-1 SECONDARY_CAS_RN
4018035 VANDF
4019779 VANDF
C0012306 UMLSCUI
CHEBI:5790 CHEBI
CHEMBL398707 ChEMBL_ID
DB00327 DRUGBANK_ID
CHEMBL1237055 ChEMBL_ID
D004091 MESH_DESCRIPTOR_UI
5284570 PUBCHEM_CID
7082 IUPHAR_LIGAND_ID
1770 INN_ID
Q812464R06 UNII
203177 RXNORM
1470 MMSL
4848 MMSL
7015 MMSL
d00255 MMSL
001547 NDDF
004622 NDDF
387485001 SNOMEDCT_US
414428000 SNOMEDCT_US
44508008 SNOMEDCT_US
Q812464R06 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Hydromorphone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0054-0264 TABLET 4 mg ORAL ANDA 33 sections
Hydromorphone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0054-0265 TABLET 8 mg ORAL ANDA 33 sections
Hydromorphone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0054-0386 SOLUTION 1 mg ORAL ANDA 33 sections
Hydromorphone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0406-3243 TABLET 2 mg ORAL ANDA 37 sections
Hydromorphone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0406-3244 TABLET 4 mg ORAL ANDA 37 sections
Hydromorphone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0406-3249 TABLET 8 mg ORAL ANDA 37 sections
Hydromorphone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0409-1283 INJECTION, SOLUTION 1 mg INTRAMUSCULAR NDA 35 sections
Hydromorphone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0409-1283 INJECTION, SOLUTION 1 mg INTRAMUSCULAR NDA 35 sections
Hydromorphone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0409-1304 INJECTION, SOLUTION 4 mg INTRAMUSCULAR NDA 35 sections
Hydromorphone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0409-1312 INJECTION, SOLUTION 2 mg INTRAMUSCULAR NDA 35 sections
Hydromorphone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0409-1312 INJECTION, SOLUTION 2 mg INTRAMUSCULAR NDA 35 sections
Hydromorphone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0409-1805 INJECTION, SOLUTION 0.25 mg INTRAMUSCULAR NDA 35 sections
Hydromorphone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0409-2540 INJECTION, SOLUTION 4 mg INTRAMUSCULAR NDA 35 sections
Hydromorphone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0409-2552 INJECTION, SOLUTION 1 mg INTRAMUSCULAR NDA 35 sections
Hydromorphone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0409-2634 INJECTION, SOLUTION 10 mg INTRAMUSCULAR ANDA 34 sections
Hydromorphone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0409-3356 INJECTION, SOLUTION 2 mg INTRAMUSCULAR NDA 35 sections
Hydromorphone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0409-3365 INJECTION, SOLUTION 2 mg INTRAMUSCULAR NDA 35 sections
Hydromorphone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0409-4264 INJECTION, SOLUTION 0.50 mg INTRAMUSCULAR NDA 35 sections
hydromorphone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0574-0293 TABLET, EXTENDED RELEASE 8 mg ORAL ANDA 33 sections
hydromorphone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0574-0294 TABLET, EXTENDED RELEASE 12 mg ORAL ANDA 33 sections
hydromorphone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0574-0295 TABLET, EXTENDED RELEASE 16 mg ORAL ANDA 33 sections
hydromorphone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0574-0297 TABLET, EXTENDED RELEASE 32 mg ORAL ANDA 33 sections
HYDROMORPHONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0574-7224 SUPPOSITORY 3 mg RECTAL Unapproved drug other 35 sections
Hydromorphone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0641-0121 INJECTION 2 mg INTRAMUSCULAR unapproved drug other 16 sections
Hydromorphone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0641-2341 INJECTION 2 mg INTRAMUSCULAR unapproved drug other 16 sections
Hydromorphone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0641-6151 INJECTION 2 mg INTRAMUSCULAR ANDA 27 sections
Hydromorphone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0641-6169 INJECTION 1 mg INTRAMUSCULAR ANDA 28 sections
Hydromorphone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0641-6170 INJECTION 2 mg INTRAMUSCULAR ANDA 28 sections
Hydromorphone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0641-6206 INJECTION 0.50 mg INTRAMUSCULAR ANDA 28 sections
Hydromorphone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0641-6254 INJECTION, SOLUTION 2 mg INTRAMUSCULAR NDA 32 sections